1 
 Korea Food and Drug Administration  
Public Announcement No. 2009 -209 
 
 
We hereby announce, in accordance with provisions in the Article 46 of the ‘Administrative 
Procedures Act’, the intent, reason and the key elements of the partial revision to ‘ Standards  and 
Specifications for Medical Devices ’; to notify the citizens in advance and to collect the public’s 
opinions.  
                                                                                                                                             
July 30, 2009  
                                                                                                                                                                                   
Commissioner,                     
Korea Food and Drug Administration  
 
 
 
 
 
Public Notice for Proposed Partial Revision to  
‘Standards and Specifications for Medical Devi ces’ 
 
 
 
1. Reason for the revision  
 
The reason for this revision is to remove the item “medical gloves” and replace it with two new 
items; “surgical gloves” and “examination gloves ”. Standards and specifications needed to 
ensure safety (such as requirement s for the raw material, safety and performance, and related 
warning messages) , will be provided with this proposal.  
 
2. Key Elements  
 
A. Removed the standards and specifications for “medical gloves” (Appendix).  
 
B. Added the standards and specifications for “surgical gloves” and “examination gloves ”  
(Appendix).  
 
(1) Established standards and specifications for performance including powder and protein 
contents in the raw materials and the end products.  
(2) Pursuant to ‘Regulations for the issuance and management of directives, established 
rules etc .’ (Presidential Directive No.248), set 3 -year review period . 
   
 
3. Presenting written opinions  2 
  
 Any individual or group who has opinion(s) about the proposed partial revision to the 
‘Standards  and Specifications for M edical Devices ’ (Attachment)  is welcome to present opinions 
in writing to the Commissioner of the Korea Food and Drug Administration ( CC: Medical 
Device Standardization Division, Address: 194 Tongilro, Eunpyeong -gu Seoul ( Postal Code: 
122-704), Phone: 02 -350-4954 Fax: 02 -350-4950)  with the following information by August 
18th, 2009 : 
 
  A. Opinions about this announcement (Whether you are for or against it and the reasoning)  
B. Your name (for groups, name of the group and name of the representative), address  and phone 
number   
C. Other references  
 
Attachment:  Proposed partial revision to the ‘Standards  and Specifications for Medical Devices ’ 
  
 
 
 
 3 
  
Korea Food and Drug Administration  
Public Notice No. 2009 - 
 
We hereby revise the ‘Standards  and Specifications  for Medical Devices ’, which is u nder the 
provision of the Article 18 of ‘Medical Devices Act’, (Korea Food and Drug Administration, 
Public Notice No. 2008 -41, Dated July 01, 2008), as follows.  
 
July xxth, 2009  
                                             
Commissioner,                                                                                                             
Korea Food and Drug Administration  
 
 
Proposed Partial Revision to  
‘Standards and Specifications for Medical Devices’  
 
‘Standards  and Specifications for Medical Devices ’ shall be revised as follows:  
 
Add the Article 4 as b elow;  
 
Article 4 (Review Period)  Pursuant to ‘Regulations for the issuance and management of 
directives, established rules etc.’ (Presidential Directive No.248), the review period for taking 
necessary measures, such as to abolish or revise this notice afte r the Act and subordinate statute 
or changes in actual circumstances etc., had been considered shall be until 00,00, 2012.  
 
Remove “medical gloves” from the Appendix, and add “surgical gloves”, “examination gloves” 
in the Enclosure respectively.  
  
 
ADDENDU M 
 
Article 1 (Date of Enforcement)  This regulation shall take effect from the date of the notice.  
 
Article 2 (Transitional Measures)  If written requests for review for “surgical gloves “and 
“examination gloves”, such as application for permission, permissi on for changes, or review of 
technical documents has already submitted at the time of the enforcement of this notice, they 
may follow the previous standards  and specifications.  
 
 
 
[Enclosure]  4 
 Surgical Gloves (Proposal)  
 
1. Scope  
The specification  provided  in this section applies to sterile rubber surgical gloves ( hereinafter 
referred to as the ‘gloves’) used in conducting surgical procedures  to protect the patient and the 
user from cross -infection. These are only applied to the disposable gloves designed t o be thrown 
away once used, and not applicable for gloves for examination or testing. Both gloves with a 
smooth surface and those that have grains are included.  
The specification is intended as a standard to the performance and safety of rubber surgical 
gloves. The safe and proper use of rubber surgical gloves, and handling, packing or sterilization 
process is beyond the scope of this specification.   
 
2. Classification  
 
The gloves are classified by the type of raw material, design and surface finishing.  
 
  A. Types of raw materials  
 
    1) Type 1: Gloves that use natural latex rubber as the base material.  
    2) Type 2:  Gloves that use nitrile rubber latex, polychloroprene  rubber latex, styrene -butadiene 
rubber sap, styrene -butadiene rubber emulsion or liqui d thermoplastic elastomer as the base 
material.  
 
B. Design  
 
1) Gloves with straight fingers (straight -finger type)  
2) Gloves with fingers bent toward the palm of the hand (bended -finger type)  
The gloves must be anatomically harmonized by letting the thumb bend t oward the palm of the 
index finger. The thumb and other fingers can be spread straight or bent towards the palm.  
 
C. Surface finishing  
 
1) Surface with grains on the entire glove or on a part of it  
2) Soft surface  
3) Powdered surface  
4) Powder -free surface  
Powdered gl oves are those that some powders were added onto the surface in order for it to be 
worn as easily as possible. Powder -free gloves do not have any p owder intentionally applied 
on them . 5 
 The edge of the sleeve can be cut or rolled.  
 
3. Raw materials  
 
Gloves a re made of natural rubber, mixed nitrile rubber or polychloroprene  rubber latex, mixed 
styrene -butadiene rubber or liquid thermoplastic elastomer, mixed styrene -butadiene rubber sap. 
Material used to make putting on the gloves  easier must comply with Attac hment 1 or the safety 
and validity must have been ensured. The talc should not be used on either the inside or the 
outside of the glove. Any colour  that is in use for gloves should be non -toxic.  
 
4. Sampling procedures  
 
A. Choosing the number of samples  
 
Use the sampling scheme specified in ISO 2859 -1. The inspection degrees and the acceptance 
quality limits (AQLs) by indexed attributes mu st comply with the facts in Table 1. If the lot size 
was not decided, choose a lot between 35001 and 150000.  
 
<Table 1> The  inspection degrees and AQLs  
 
Attributes  Inspection  
Degrees  AQLs  
Physical Size (Width, Length, Thickness)  S-2 4.0 
Water tightness  G-1 1.5 
Tensile strength and the coefficient of expansion (before and after the 
accelerated aging) at the break point, and  tensile stress (before the 
accelerated aging) when 300% elongated  S-2 4.0 
 6 
  
B. Choosing test pieces  
 
When test pieces are required, they must be taken from the palm or the back of the glove.  
 
5. Requirements  
 
A. Size  
 
1)  When measured the size at the poi nts specified in Figure 1 using the inspection degrees 
and AQLs in Table  1, the width and the length of glove must fit with the standards in Table 2. 
The length should be the shortest distance between the end of the middle finger and the end of 
the sleeve.  The length can be measured by hanging the glove on a proper mandrel that has a 
radius of 5mm.  
2)  The width must be measured in between the bottom of the index finger and the thumb. The 
glove should be placed on a flat surface in order to measure the widt h. 
3)  According to the ISO 23529, the twofold  thickness of a glove without deformation should 
be measured at the points shown in the Figure2. Apply a pressure of 22±5 kPa to each of 
following point respectively; a point that apart 13±3 mm from the top of middle finger; 
approximately at the centre  of palm; 25±5 mm from the edge of sleeve. Record a half of the 
measured twofold  thickness as onefold thickness, and it must be suited with sizes in Table 2 
when the inspection degrees and the AQLs in Table 1 is us ed.  
If any thinner part was found from the exterior inspection, the onefold  thickness should be 
measured at that part. The onefold  thickness of slippery and grained parts should be thinner 
than 0.10mm and 0.13mm respectively.  
4)  The approximate  centre  of palm is 48±9 mm apart from either side.  
5)  When measured based on ISO 23529, the thickness of the end of sleeve should not exceed 
2.50mm.  
 7 
 
 
<Figure 1> Points to measure the Width and Length  (unit: mm)  
 
 
 
 
Size 
Code  Width(W)  
W in the Figure 1  Minimum Len gth (L)  
L in the Figure 1  Minimum Thickness  
(The same point as in the Figure 2)  
5 67±4  250 
5.5 72±4  250 
6 77±5  260 
6.5 83±5  260 
7 89±5  270 
7.5 95±5  270 
8 102±6  270 
8.5 108±6  280 
9 114±6  280 
9.5 121±6  280 For all sizes,  
Smooth area:0.10  
Grained area:0.13  
<Table 2> Sizes and the Permissible Error  
 
 8 
 
 
<Figure 2> Points to measure the Thickness  (unit: mm)  
 
 
B. Watertightness  
 
The acceptable number of non -suitable gloves (that are leaking water) in the number of 
samples and the chart should c omply with Table 1.  
As shown in Figure 3, attach a glove to an empty cylindrical mandrel that has capacity of 
1000mL and a minimum outer diameter of 60mm. Use an appropriate device such as an O 
ring to hang the glove and do not place the glove more than 40  mm above the mandrel. Fill 
the device with 1000±50 mL of water of which the temperature does not exceed 36 °C. Dry 
the surface of glove, and if water was not filled up to 40mm from the end of sleeve, lift the 
glove up such that every parts of the glove other than the area 40mm below the end of sleeve 
can be tested. When a symptom of water leakage appears, immediately record it. If immediate 
leakage was not found, wait 2~4 minutes and then observe again. Ignore any leakage in the 
area 40mm below the end of sleeve. The water may be coloured with water -soluble dyes to 
make the observation easier.  9 
 
 
<Figure 3> Mandrel for Watertightness testing  
(1: Ring 2: Cylinder 3: Scale marks on inside walls)  
 
 
 
 
<Figure 4> Rack fo r Watertightness testing  
 
 10 
  
 
C. Elongation  
 
 1) Test pieces preparation  
Collect test pieces in dumbbell shape from the palm and the back of each glove based on ISO 
25329.    
 2) The strength and the coefficient of expansion before the accelerated aging at the break point  
Place the dumbbell -shaped test piece on the grip or pulley of the elongation test device. 
Ensure that the test piece is not twisted. Put the maximum load on the test piece until it is 
broken when 300 % extended with 500±25 mm/min. The tensi le strength at the break point, 
required tensile strength when extending 300% should comply with Table 3 when the 
inspection level and AQL given in Table 1 were used.   
 
<Table 3> Attributes of Elongation  
Requirements  
Attributes  Type 1 
Gloves  Type 2 
Glov es 
Minimum strength at the break point before the accelerated aging  12.5 9.0 
Minimum coefficient of expansion  at the break point before the 
accelerated aging, %  700 600 
Required tensile strength with 300% expansion before the 
accelerated aging, N  2.0 3.0 
Minimum strength at the break point after the accelerated aging, 
N 9.5 9.0 
Minimum coefficient of expansion  at the break point after the 
accelerated aging, %  550 500 
 
 3) The strength and the coefficient of expansion at the break point after the accel erated aging  
Take the dumbbell shaped test piece from a glove that has been aged at 70±2 °C for 168±2 
hours. The tensile strength and the coefficient of expansion at the break point  should comply 
with Table 3 when inspec tion level and AQL given in Table 1 are used.  
 4) Required strength when extending 300%  
When testing the 2nd dumbbell shaped test piece according to the method stipulated in ISO 37, 
the required strength when extending 300% should comply with Table 3 when inspec tion 
level and AQL given in Table 1 were used.  
 
D. The amount of powder and the powder residue  
 
The amount of powder on the surface of a glove used to make putting on the gloves  easier should 
be less than 15 mg/cm2 when tested based on ISO 211 71. Powder residue on a powder -free glove 
should be less than 2 mg.  11 
  
E. The protein content  
 
1)  Water -extractable protein content  
Determine the amount of water -extractable protein (g/mL) in each test piece according to 
ISO 12243 (ASTM D 5712). Multiply t he resulting value by the total amount of agent to 
determine the total g of water -extractable protein content per each glove sample. Calculate 
the size of the glove in mm2. According to Table 2, multiply the minimum length and width 
(cm2/mm2), then conver t it to cm2 using mm2/10000. Take into account both the interior and 
exterior when calculating the area of the glove. Divide the resulting total g of protein by the 
total area of the glove to determine the water -extractable protein content in the sample g love. 
The result should be less than 200 g/cm2 for powdered glove, and 50 g/cm2 for powder -free 
glove. If more than one test piece were used, use the average protein content (g/cm2) of the 
test pieces.  
2)  Antigenic protein content  
Determine the amount of antigenic protein (g/mL) in each test piece according to ASTM D 
6499. Multiply the result value by the total amount of agent to determine the total g of 
extractable antigenic protein content per each glove sample. Calculate the size of the glove in 
mm2. Divide the total g of antigenic protein by the total area of the glove to determine the 
extractable antigenic protein content in the sample glove. The amount should be less than 10 
g/cm2. 
 
F. Sterilization  
 
The gloves should be sterilized and the ster ilization process should be recorded as required.   
 
6. Packing  
 
Gloves should be packed with twofold packing materials.  
 
7. Items to be displayed on the package  
 
Items stipulated in the ‘Regulation for Evaluation of Technical Documents on Medical Devices 
etc.’ (KFDA Public Notice) that has been notified by the Commissioner of the Korea Food and 
Drug Administration, including the following items, should be displayed on the packages.  
 
A.  Name of the product  
B.  Business name, address, phone number and fax n umber of the manufacturer or importer 
(including retailer)  
C.  The origin, if it is an imported product (Country of the production, name of the manufacturer)  
D.  Manufacturer permit number, import permit number or manufacture/import item permit 
number  
E.  The manufacture r’s serial number, the date of manufacture, weight or capacity, quantity and 
price, expiration date  
F.  Instructions (including the performance) and directions for use or warning, keeping direction  
 12 
 # For powdered latex surgical gloves, the following warning message must be included in the 
‘Directions for Use’ section.  
1) When using powdered latex surgical gloves, the powder residue on the surface of gloves 
can deepen the allergic reaction. Be sure to remove the powder with asepsis before the 
surgical procedure to minimize the risk of side effects.  
2) The antigen of latex allergy is spread through the air by the powder. If there are concerns 
about potential outbreak of latex allergy among the patients in an operating room or the 
medical staff, do no t use this product.  
 
G.  Other necessary items  
 
1)  Size  
2) “Left” or “L” and ”Right ” or “R” marked on the package  
3)  A phrase “Straight -finger type” or “Bended -finger type”, or appropriate phrase about the 
effect of the glove design type  
4)  Phrases “Gra ined” or “Smooth”, “Powdered” or “Powder -free”, or appropriate phrase about 
the surface finishing of the gloves  
5)  Confirmed lot number of the manufacturer  
6)  A phrase about the “Date of Manufacture” or influences, and 4 -digit year and month of the 
manuf acture  
7)  A phrase “This product is in sterilized condition when the package is not opened or there is 
no damage on the product”  
8)  A phrase “Disposable”  
9)  A phrase “Surgical Gloves”  13 
  
[Attachment 1] Substance to make putting on the gloves easy (Absorb able Dusting Powder)  
 
Absorbable dusting powder is used as a lubricant for surgical gloves. The magnesium oxide in 
the powder should be less than 2%.  
 
1. Packing and storing  
It must be kept in tightly sealed containers or sealed paper bags.  
 
2. State  
1/10 suspension distilled water turn to dark blue from blue by iodine TS.  
 
3. Safety of sterilization  
Put about 2g of powder into an appropriate paper bag and seal. Wrap the paper bag with muslin 
cloth; heat at 121 °C for 30 minutes and cool it down. The powder should not become hard, and 
the chunks must be crumbled easily with fingers.  
 
4. Precipitation  
Boil 100mL of 1/10 suspension distilled water for 10 minutes; move it into 100mL cylinder with 
scale marks and leave as  it is. The amount of precipitated powder should be between 45 mL and 
75 mL.  
 
5. PH  
1/10 suspension should be between 10.0 ` 10.8.  
 
6. Weight reduction by drying  
Dry approximately 2g of the powder at 105 °C; weigh p recisely. Reduced amount should be less 
than 12%.  
 
7. Residue from high temperature  
Heat 1g of the powder in a platinum crucible; remove the lid and weigh the residue. The residue 
should be less than 3%.  
 
8. Heavy metals  
Should be less than 0.001%.  
 
9. Mag nesium oxide  
Measure 2.5 g of the powder precisely and put it into a beaker. Mix it with 25mL of water and 
2mL of hydrochloric acid for 5 minutes. Add 5mL of hydroxylamine  
hydrochloride solution (1/10), 15 mL of ammonia ammonium TS, 5mL of potassium  
cyani de solution (1/10) 5 , and 5 drops of eriochrome black TS and blend well.  Coordinate 
with 0.05 concentration of disodium ethylenediaminetetraacetate until the solution became clear 
blue colour . Each mL of 0.05 concentration of disodium ethylenediaminetetraacetate is 
equivalen t to 2.015 mg of magnesium oxide.  14 
  
Examination Gloves (Proposal)  
1. Scope  
The specification  provided in this section applies to sterile rubber examination gloves (including 
non-sterilized rubber examination gloves) or polymer gloves ( hereinafter referred  to as the 
‘gloves’) used in patients examination, diagnose and treatment in order to protect patient and the 
user from cross infection. The gloves used to handle contaminated medical substances are 
included. B oth gloves with smooth surface and gloves that  have grains are included.  
This specification is intended as a standard to the performance and safety of rubber examination  
gloves. The safe and proper use of rubber examination  gloves, handling, packing and sterilization 
process are beyond the scope of th is specification.   
 
2. Classification  
 
The gloves are classified by the type of the raw material, design and surface finishing.  
 
 A. Types  
   
Applicable only for rubber examination gloves;  
 
    1) Type 1: Gloves that use natural latex rubber as the base m aterial.  
    2) Type 2:  Gloves that use nitrile rubber latex, polychloroprene  rubber latex, styrene -butadiene 
rubber sap, styrene -butadiene rubber emulsion or liquid thermoplastic elastomer as the base 
material.  
 
 B. Surface finishing  
 
1) Surface with grains on the entire glove or on a part of it  
2) Soft surface  
3) Powdered surface  
4) Powder -free surface  
Powdered gloves are those that some powders were added on the surface in order for it to be 
worn as easily as possible. Powder -free gloves do not have any powder inten tionally applied 
on it.  
The edge of the sleeve can be cut or rolled.  15 
  
3. Raw materials  
 
1) Examination rubber gloves are made of natural rubber, or mixed nitrile rubber or 
polychloroprene  rubber latex, or mixed styrene -butadiene rubber or liquid thermoplasti c 
elastomer, or mixed styrene -butadiene rubber sap.  
2) Examination polymer gloves are made of plastic polymer.  
3) Material used to make putting on the gloves  easier must comply with Attachment 1 or the 
safety and validity has been ensured. The talc should not b e used on either the inside or the 
outside of the glove. Any colour  that is in use for gloves should be non -toxic.  
 
4. Sampling procedures  
 
A. Choosing the number of samples  
 
Use the sampling scheme specified in ISO 2859 -1. The inspection degrees and the acceptance 
quality limits (AQLs) by indexed attributes must comply with the facts in Table 1. If the lot size 
was not decided, choose a lot between 35001 and 150000.  
 
<Table 1> The inspection degrees and AQLs  
Attributes  Inspection  
Degrees  AQLs  
Physical Size ( Width, Length, Thickness)  S-2 4.0 
Water tightness  G-1 2.5 
Tensile strength and the coefficient of expansion (before and after the 
accelerated aging) at the break point, and tensile stress (before the 
accelerated aging) when elongated 300%  S-2 4.0 
 
  B.  Choosing test pieces  
 
When test pieces were required, they must be taken from the palm or the back of the glove.  
 
5. Requirements  
 
A. Size  
 
 1) When measured the size at the points specified in Figure 1 using the inspection degrees and 
AQLs in Table  1, the width and the length of the palm must fit within the standards in Table 2. 
The length should be the shortest distance between the end of the middle finger and the end of 16 
 the sleeve. The length can be measured by hanging the glove on a proper mandrel wit h 5mm 
in radius.  
 2) The width should be measured in between the bottoms of the index finger and the thumb. The 
glove should be placed on a flat surface in order to measure the width.  
 3) According to the ISO 23529, the twofold thickness of a glove without  deformation should be 
measured at the points shown in the Figure2. Apply a pressure of 22±5kPa to each point 
respectively; a point that apart 13±3 mm from the top of middle finger; approximately at the 
centre  of palm; and 25±5 mm from the edge of sleeve. Record a half of the measured two fold 
thickness as onefold thickness, and it must be suited with sizes in Table 2 when the inspection 
degrees and the AQLs in Table 1 are used.  
If any thinner part was found from the exterior inspection, the onefold thickne ss should be 
measured at that part. The onefold thickness of slippery and grained parts should be thinner 
than 0.08mm and 0.11mm respectively.  
 4) The approximate  centre  of the palm is 48±9 mm apart from either side.  
 5) When measured based on ISO 23529, t he thickness of the end of the sleeve should not exceed 
2.50mm.  17 
  
 
 
 
 
<Figure 1> Locations to measure the Width and Length  (unit: mm)  
 
 
 
Size 
Code  Width by 
Size (W in 
Figure 1)  Descriptive 
Size Width by 
Descriptive 
Size (W in 
Figure 1)  Minimum 
Length (L 
in Figure 1)  Minimum 
Thickness  
(The same 
location as 
in Figure 2)  Maximum 
Thickness  
(At the 
centre  of 
palm)  
Smaller 
than 6  82 Extra Small 
(X-S) 80 220 
6.5 83±5  Small (S)  80±10  220 
7 89±5  230 
7.5 95±5  Medium (M)  95±10  230 
8 102±6  230 
8.5 108±6  Large (L)  110±10  230 
Larger 
than 9  110  Extra Large 
(X-L) 110  230 Smooth 
area:0.08  
Grained 
area:0.11  Smooth 
area:2.00  
Grained 
area:2.03  
<Table 2> Sizes and the Permissible Error (unit: mm)  
 18 
  
 
<Figure 2> Location to measure the Thickness  (uni t: mm)  
 
  
B. Watertightness  
 
The acceptable number of non -suitable gloves (that are leaking water) in the number of 
samples and the chart should comply with Table 1.  
As shown in Figure 3, attach a glove to an empty cylindrical mandrel that has capacity of 
1000mL and a minimum outer diameter of 60mm. Use an appropriate device such as an O 
ring to hang the glove and do not place the glove more than 40 mm above the mandrel. Fill 
the device with 1000±50 mL of water of which the temperature is not exceeding 36 °C. Dry 
the surface of the glove. If water was not filled up to 40mm from the end of sleeve, lift the 
glove up such that every parts of the glove other than the area 40mm below the end of sleeve 
can be tested. When a symptom of water leakage appears, immediately record it. If immediate 
leakage was not found, wait for 2~4 minutes and then observe again. Ignore any leakage in 
the area 40mm below the end of sleeve. The water may be coloured  with water -soluble dyes 
to ma ke the observation easier.  
 
 19 
 
 
<Figure 3> Mandrel for Watertightness testing  
(1: Ring 2: Cylinder 3: Scale marks on inside walls)  
 
 
 
 
<Figure 4> Rack for Watertightness testing  
 
 
 
 20 
 C. Elongation  
 
1) Test pieces preparation  
       Collect test pieces in dumbb ell shape from the palm and back of each glove based   
       on ISO 25329.    
 2)  The strength and the coefficient of expansion before the accelerated aging at the break point  
Place the dumbbell shaped test piece on the grip or pulley of the elongation t est device. 
Ensure the test piece is not twisted. Put the maximum load on the test piece until it is broken 
with 500±25 mm/min. The tensile strength and the coefficient of expansion  at the break 
point should fit with Table 3 when inspection level and AQL g iven in Table 1 are used.   
 
<Table 3> Attributes of Elongation  
Requirements  
Attributes  Type 1 
Gloves  Type 2 
Gloves  
Minimum strength at the break point before the accelerated aging  7.0 7.0 
Minimum coefficient of expansion  at the break point before the 
accelerated aging, %  650 500 
Minimum strength at the break point after the accelerated aging, 
N 6.0 7.0 
Minimum coefficient of expansion  at the break point after the 
accelerated aging, %  500 400 
 
2) The strength and the coefficient of expansion at the brea k point after the accelerated aging  
Take a dumbbell shaped test piece from a glove that has been aged at 70±2 °C for (168±2) 
hours. Put a load on the test piece in the way as before the accelerated aging.  The tensi le 
strength and the coefficient of expansion at the break point  should fit with Table 3 when 
inspec tion level and AQL given in Table 1 were used.  
 
D. The amount of powder and the powder residue  
 
The amount of powder on the surface of a glove used to make p utting on the gloves  easier should 
be less than 10 mg/cm2 when tested based on ISO 21171. Powder residue per powder -free glove 
should be less than 2 mg.  
 21 
  
E. The protein content  
 
 1)  Water -extractable protein content  
Determine the amount of water -extract able protein (g/mL) in each test piece according to 
ISO 12243 (ASTM D 5712). Multiply the result value by the total amount of agent to 
determine the total g of water -extractable protein content per each glove sample. Calculate 
the size of the glove in mm2. According to Table 2, multiply the minimum length and width 
(cm2/mm2), then convert it to cm2 using mm2/10000. Take into account both the interior and 
the exterior surfaces when calculating the area of the glove. Divide the resulted total g of 
protein by the total area of the glove to determine the water -extractable protein content in 
the sample glove. The result should be less than 200 g/cm2 for a powdered glove, and 50 
g/cm2 for a powder -free glove. If more than one test pieces were used, use the av erage 
protein content (g/cm2) of test pieces.  
 2) Antigenic protein content  
Determine the amount of antigenic protein (g/mL) in each test piece according to ASTM D 
6499. Multiply the result value by the total amount of agent to determine the total g of 
extractable antigenic protein content per each glove sample. Calculate the size of the glove in 
mm2. Divide the total g of antigenic protein by the total area of the glove to determine the 
extractable antigenic protein content in a sample glove. The amoun t should be less than 10 
g/cm2. 
 
F. Sterilization  
 
The gloves should be sterilized and the sterilization process should be recorded as required.   
 
6. Packing  
 
Sterilized gloves should be packed individually or as a pair.  
 
7. Items to display on the packa ge 
 
Items stipulated in the ‘Regulation for Evaluation of Technical Document on Medical Devices 
etc.’ (KFDA Public Notice) that has been notified by the Commissioner of the Korea Food and 
Drug Administration, including the following items, should be displa yed on the packages.  
 
A.  Name of the product  
B.  Business name, address, phone number and fax number of the manufacturer or importer 
(including retailer)  
C.  The origin of imported products (country of the production, name of the manufacturer)  
D.  Manufacturer permit number, import permit number or manufacture/import item permit 
number  
E.  The manufacture r’s serial number, the date of manufacture, weight or capacity, quantity and 
price, expiration date  
F.  Instructions (including the performance ) and directions for use or warning, keeping direction  
 22 
 # For powdered latex examination gloves, the following warning message must be included in 
the ‘Directions for Use’ section.  
1) When using powdered latex surgical gloves, the powder residue on the surfac e of the 
gloves can deepen the allergic reaction. Be sure to remove the powder with asepsis before 
the surgical procedure to minimize the risk of side effects.  
2) The antigen of latex allergy is spread through the air by the powder. If there are concerns 
abou t potential outbreak of latex allergy among the patients in an examining room or the 
medical staff, do not use this product.  
 
G.  Other necessary items  
 
1) Size 
2) “Left” or “L” and “Right” or “R” marked on the package  
3) A phrase “Straight -finger type” or “ Bended -finger type”, otherwise an appropriate phrase 
about the effect of the glove design  
4)  Phrases indicating “Grained” or “Smooth”, “Powdered” or “Powder -free”, or appropriate 
phrase about the surface finishing of the gloves  
5)  Confirmed lot number of  the manufacturer  
6)  A phrase about the ‘Date of Manufacture” or influences, and 4 -digit year and month of the 
manufacture  
7)  A phrase “This product is in sterilized condition when the package is not opened or there is 
no damage on the product”  
8)  A phr ase “Disposable”  
9)  A phrase “Examination Gloves”  23 
  
[Attachment 1] Substance to make putting on the gloves easy (Absorbable Dusting Powder)  
 
Absorbable dusting powder is used as a lubricant for surgical gloves. The magnesium oxide in 
the powder should be less than 2%.  
 
1. Packing and storing  
It must be kept in tightly sealed containers or sealed paper bags.  
 
2. State  
1/10 suspension distilled water turn to dark blue from blue by iodine TS.  
 
3. Safety of sterilization  
Put about 2g of powder into an appropri ate paper bag and seal. Wrap the paper bag with muslin 
cloth; heat at 121 °C for 30 minutes and cool it down. The powder should not become hard, and 
the chunks must be crumbled easily with fingers.  
 
4. Precipitatio n 
Boil 100mL of 1/10 suspension distilled water for 10 minutes, then move it into 100mL cylinder 
with scale marks and leave as it is for 24 hours. The amount of precipitated powder should be 
between 45 mL and 75 mL.  
 
5. PH  
1/10 suspension should be between  10.0 ` 10.8.  
 
6. Weight reduction by drying  
Dry approximately 2g of the powder at 105 °C, and then weigh precisely. Reduced amount 
should be less than 12%.  
 
7. Residue from high temperature  
Heat 1g of the powder in  a platinum crucible; remove the lid and weigh the residue. The residue 
should be less than 3%.  
 
8. Heavy metals  
Should be less than 0.001%.  
 
9. Magnesium oxide  
Measure 2.5 g of the powder precisely and put it into a beaker. Mix it with 25mL of water and 
2mL of hydrochloric acid for 5 minutes. Add 5mL of hydroxylamine  
hydrochloride solution (1/10), 15 mL of ammonia ammonium TS, 5mL of potassium  
cyanide solution (1/10) 5 , and 5 drops of eriochrome black TS and blend well.  Coordinate 
with 0.05 concentration  of disodium ethylenediaminetetraacetate until the solution became clear 
blue colour . Each mL of 0.05 concentration of disodium ethylenediaminetetraacetate is 
equivalent to 2.015 mg of magnesium oxide.  24 
  
 
 
Comparison of New and Old Provision  
-------------- ----------------------------------------  
 
Current  Proposed  
 
<New>  Article 4 (Review Period)  Pursuant to 
‘Regulations for the issuance and 
management of directives, established rules 
etc.’ (Presidential Directi ve No.248), the 
review period for taking necessary 
measures such as to abolish or revise this 
notice after the Act and subordinate statute 
or changes in actual circumstances etc. had 
been considered shall be until 00 00th, 
2012.