**Date: 22 July, 2003**

**FROM: Malaysian Rubber Glove Manufacturers' Association (MARGMA)**

**A2-20 PJ Industrial Park,**

**Jalan Kemajuan, Sec.13,**

**46200 Petaling Jaya**

##  Selangor, Malaysia

**Tel: 603-7957 8362 Fax 603 7957 8412**

**E-mail: <margma@tm.net.my>**

**TO: Dockets Management Branch (HFA-305),**

> **Food and Drug Administration,**
>
> **5630 Fishers Lane, Rm. 1061,**
>
> **Rockville, MD 20852.**

Reference : Docket: No. 00D-1384. Additional Comments by MARGMA

Subject: Import Alert IA 80-04

The Malaysian Rubber Glove Manufacturers' Association (MARGMA) is an
association of 52 manufacturers of medical gloves. See Attachment 1 for
a list of current glove manufacturers who are members of MARGMA.

MARGMA manufacturers shipped about 1.2 billion pairs surgeons' gloves
and 8.7 billion pairs examination gloves to the Unites States in year
2002.

The following additional comments are submitted by MARGMA, representing
52 manufacturers, and was developed with the collaboration of our US
Regulatory Affairs Consultant, Mr. Andrew Lowery.

MARGMA notes that the present or proposed 800.20 is implemented with 21
CFR Part 820 GMP/QS and Import Alert #80-04. Therefore, MARGMA
respectfully requests that FDA review the current Import Alert #80-04
guidance, "***Surveillance and Detention without Physical Examination"
\[DWPE***\] together with the new proposed rule identified immediately
below:

***800.20 Medical Devices; Patient Examination and Surgeons' Gloves;
Test Procedures and Acceptance Criteria.***

*Reference: Docket No. 03N-0056.*

*Federal Register: March 31, 2003 (Volume 68, Number 61) (Proposed
Rules) (Page 15404-15417) 21 CFR Part 800*

Sincerely Yours,

Andrew Tan

Executive Director

**Malaysian Rubber Glove Manufacturers\' Association**

*Attachments 2*

ADDITIONAL COMMENTS ON IA 80-04

**MARGMA has submitted comments on IA 80-04 and we would like to submit
the additional following comments.**

**Comment:** Where IA 80-04 calls for 5 or 10 consecutive good shipments
to get off DWPE after a failure, please make it **clear** that it is 5
or 10 good shipments after the failure and not 5 or 10 consecutive good
shipments to get off DWPE after FDA places the manufacturer/shipper on
the alert list.

Rationale: The additional delay is much more punitive. While under
detention, a manufacturer pays the cost of testing; however, much more
important, is the loss of business and loss of customers because they
move, and must move, to other suppliers if it appears that there will be
continued delays in getting gloves released.

The delays have and extremely serious negative impact on the 'detained'
manufacturer. That is, MARGMA believes that the Recidivist Policy was
intended to achieve corrective action rather than forcing a manufacturer
out of the glove business.

**Comment:** Where IA 80-04 calls for 5 or 10 consecutive good shipments
to get of DWPE after a failure, please make it **clear** that it is not
consecutive good shipments for 6 months or more to get off DWPE after
FDA places the manufacturer/shipper on the alert list.

**Rationale:** One of our manufacturers has been subjected to 6 months
of good shipments before getting off DWPE rather than the required 5
good shipments with no reason given for the private requirements. The
additional delay is devastating and is not in IA 80-04. While under
detention, this manufacturer pays the cost of testing; however, much
more important, is the loss of business and loss of customers because
their customers move, and must move, to other suppliers if delays in
getting gloves released will **continue for more than 6 months**. MARGMA
believes that FDA employees should follow the text and intent of IA
80-04 rather than setting arbitrary and devastating policy. Such
arbitrary policy destroys the FDA promoted concept of a level playing
field.

Copy of IA 80-04 for reference.

IA #80-04

REVISED 9/11/97, IMPORT ALERT #80-04, \"SURVEILLANCE AND DETENTION
WITHOUT PHYSICAL EXAMINATION OF SURGEON\'S AND OR PATIENT EXAMINATION
GLOVES

ATTACHMENT A - 3/15/01, ATTACHMENT B - 8/1/00

(NOTE: This import alert represents the Agency\'s current guidance to
FDA field personnel regarding the manufacturer(s) and/or product(s) at
issue. It does not create or confer any rights for or on any person, and
does not operate to bind FDA or the public.

REASON FOR REISSUANCE: A new procedure was developed for detention
without physical examination of gloves manufactured by firms who
repeatedly import non-compliant products.

TYPE OF ALERT: Surveillance (Physical Examination), and Detention
Without Physical Examination

PRODUCT: Surgeon\'s and Patient Examination Gloves

PRODUCT CODE: 80LZA, 80FMC, 80LYY, 80LZC, 80LYZ, 79KGO

PAC: 82Z003

PROBLEM: Defective per 21 CFR 800.20 - Leaks, tears, mold, embedded
foreign objects

COUNTRY: Surveillance - All Countries - (ZZ) Detention Without Physical
Examination - See Attachments (A & B)

MANUFACTURER/ SHIPPER: See Attachments (A & B)

MANUFACTURER/ SHIPPER ID#: N/A

IMPORTER\'S ID #: N/A

CHARGE: \"The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to contain defects/holes
\[Adulteration, section 501(c).\]\"

When FDA has documented repeated violations, and the
manufacturer/shipper has been issued a Warning Letter and listed in
Attachment B of the Recidivist Policy described below, future shipments
may be detained charging the following:

\"The article is subject to refusal of admission pursuant to section
801(a)(1) in that it appears that the methods used in, or the facilities
and controls used for, the manufacture, packaging, storage, or
installation of the device do not conform with Good Manufacturing
Practices \[Adulteration, section 501(h), Good Manufacturing Practices,
Section 520(f).\]\"

RECOMMENDING OFFICE: Center for Devices and Radiological Health (CDRH)

REASON FOR ALERT: CDRH has determined that many foreign manufacturers
and shippers of medical gloves have failed to consistently provide
medical gloves of adequate quality for distribution in the U. S.
Surgeon\'s and examination gloves are widely used by health care
professionals and others as a barrier to blood-borne diseases and
pathogens. Defective medical gloves present a potential hazard to health
for users as well as patients. Therefore, continuous monitoring of these
medical gloves is needed.

GUIDANCE: Districts may detain without physical examination, all
shipments of surgeon\'s and patient examination gloves from the
manufacturers/shippers listed on the attachments to this alert.

Surveillance sampling of other manufacturers/shipper\'s surgeon\'s and
patient examination gloves per the most recent guidance is indicated.

NOTE: Because the presence of defects in medical gloves represents a
potential hazard to health, only one (1) violative sample is needed to
submit a recommendation for detention without physical examination to
the Division of Import Operations & Policy (DIOP). DIOP has direct
reference authority for detention without physical examination of these
medical gloves. Violative medical gloves are subject to RPM Chapter 9,
Detention Without Physical Examination, subchapter \"Recommendations
Based on One Sample.\"

The following strategy has been established to address those
manufacturers/shippers who are found to repeatedly ship violative
medical gloves to the U.S. (recidivist firms.)

Level 1 Detention (INDICATED BY \* IN ATTACHMENT A)

When a district encounters a shipment of medical gloves which is found
violative for defects by FDA analysis, the shipment should be detained
and a recommendation for detention without physical examination should
be forwarded to DIOP, HFC-170.

If the recommendation meets current guidance, the manufacturer/shipper
will be placed on attachment \"A\" with a single asterisk(\*), and
subsequent medical glove shipments from that manufacturer/shipper may be
detained without physical examination under this import alert. This is
referred to as \"Level 1 detention.\" The manufacturer/ shipper may
obtain admission of subsequently detained shipments of medical gloves by
presenting evidence that the individual shipments are not adulterated,
such as sample analyses performed by an independent testing laboratory,
following the sampling plan and test method contained in FDA guidance.

In order for the responsible manufacturer\'s/shipper\'s name to be
removed from attachment \"A,\" documentation should be provided with
sufficient evidence that their medical gloves are not adulterated (for
example, five consecutive non-violative shipments analyzed as described
in the preceding paragraph may be considered adequate evidence for
manufacturers/shippers to be removed from Level 1 detention).

Level 2 Detention \-- (Recidivist firms which are currently on Level 1
detention, or which have been removed from Level 1 detention) (INDICATED
BY \*\* IN ATTACHMENT A)

If a manufacturer/shipper, while on Level 1 detention, has a violative
sample analyzed by a private laboratory, the district should notify DIOP
and submit supporting documentation. DIOP will place the firm on Level 2
detention and identify the manufacturer/shipper on attachment \"A\" with
two asterisks (\*\* ).

Similarly, if a manufacturer/shipper that has been removed from Level 1
detention has a violative sample analyzed by FDA within 24 months from
the date they were removed from Level 1 detention, the district should
notify DIOP and submit supporting documentation. DIOP will verify the
manufacturer/shipper was listed under Level 1 detention during the past
24 months and if confirmed will place the manufacturer/shipper on Level
2 detention and identify the manufacturer/shipper on attachment \"A\"
with two asterisks(\*\* ).

DIOP will bring this action to the attention of CDRH.

Based on this second listing within 24 months, CDRH has agreed to notify
the foreign firm in writing of FDA\'s concerns about potential
deficiencies in the manufacturing practices and process controls which
may be affecting the quality of the medical gloves shipped to the U.S. A
copy of the Good Manufacturing Practices (GMP) Regulations will be
provided with the letter for their information.

Once a manufacturer/shipper is placed on Level 2 detention, FDA may need
greater assurance that the medical gloves are not adulterated before
removing the manufacturer/shipper from detention without physical
examination status. For example, 10 consecutive non-violative shipments,
analyzed by an independent testing laboratory, may be considered
adequate evidence that the manufacturer/shipper is shipping medical
gloves to the U.S. which are not adulterated. Other types of evidence to
remove the appearance of a violation will be evaluated by CDRH on a
case-by-case basis.

Level 3 Detention \-- (Recidivist firms which are currently on Level 2
detention, or which have been removed from Level 2 detention) (\*\* \*
IN ATTACHMENT A DENOTES A WARNING LETTER IS BEING CONSIDERED BY CDRH)

If a manufacturer/shipper, while on Level 2 detention, has another
violative sample analyzed by an independent testing laboratory, the
district should notify DIOP and submit supporting documentation.

Similarly, if a manufacturer/shipper removed from Level 2 detention has
another violative sample analyzed by FDA within 24 months from the date
they were removed from Level

1 detention, or the date they were placed on Level 2 detention, DIOP
will bring these instances to the attention of CDRH.

Based on the failure of the manufacturer\'s/shipper\'s medical gloves to
pass FDA analysis \[Section 501(c)\] after being listed on Level 2
detention, or having failed an independent testing laboratory
examination while under Level 2 detention, CDRH may then issue a Warning
Letter to the firm.

Additionally, after reviewing the manufacturer/shipper\'s export and
inspectional history, CDRH may elect to charge the firm for failure to
conform with GMP's \[Section 501(h)\], based on the recurring GMP
deficiencies as revealed by the repeated failures of analyses.

If CDRH determines a warning letter should issue to the foreign
manufacturer/shipper, DIOP will place the manufacturer/shipper on Level
3 detention (attachment B).

Non-violative analyses may not be sufficient to remove the appearance of
a violation for manufacturers/shippers on attachment B.
Manufacturers/shippers will remain on Level 3 detention until evidence
is provided to CDRH which demonstrates that the medical gloves are being
manufactured in accordance with Good Manufacturing Practices (for
example, an acceptable FDA inspection or a written certification from
the manufacturer/shipper together with the results of an independent
audit performed by a qualified third party).

Once a foreign manufacturer/shipper satisfactorily demonstrates that the
apparent GMP deviations have been corrected, the manufacturer/shipper
will be removed from attachment \"B\" and placed on attachment \"A\"
under the Level 1 detention for individual shipment analysis to confirm
their medical gloves do not contain defects until they provide adequate
evidence to be removed from Level 1 detention (see above).

For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology, contact
the Division of Field Science at (301)

443-3320 or 3007.

For questions concerning 21 CFR 800.20, CPG 7124.31, medical glove
labeling, or other compliance issues, contact CDRH, Office of
Compliance, Division of Enforcement II at (301)

594-4618.

SAMPLING: See 21 CFR 800.20(c) for sample plans.

All sizes should be represented as closely as feasible to the proportion
which they exist in the shipment, however, exact statistical
representation is not necessary. If the sample is found violative, all
sizes should be detained.

When an entry consists of only one size, attempt to collect as many lot
numbers as possible. For example, if during a random sample collection
three lot numbers are observed, represent them all as subs within one
sample. If the sample is found violative, all lots should be detained.

If a shipment is detained based on the analysis of one lot and
subsequently it is learned that there were 10 lot numbers present, the
detention stands.

**ATTACHMENT 1:**

LIST OF MEMBER COMPANIES

**\[ORDINARY (Manufacturing) MEMBERS\]**

**MALAYSIAN RUBBER GLOVE**

**MANUFACTURERS' ASSOCIATION**

**(MARGMA)**

+-----------------------------------+----------------------------------+
| 1.  Alliance Rubber Products Sdn  | 26. Oon Corp Resources (M) Sdn   |
|     Bhd                           |     Bhd                          |
|                                   |                                  |
| ```{=html}                        | 27. Pan Century Rubber Products  |
| <!-- -->                          |     Sdn Bhd                      |
| ```                               |                                  |
| 1.  Ansell (Kedah) Sdn Bhd        | 28. Perusahaan Getah Asas Sdn    |
|                                   |     Bhd                          |
| 2.  APL Healthcare Sdn Bhd        |                                  |
|                                   | 29. Perusahaan Pelindung         |
| 3.  Apollo Rubber Sdn Bhd         |     Getah (M) Sdn Bhd            |
|                                   |                                  |
| 4.  Brightway Holdings Sdn Bhd    | 30. Protection Gloves (M) Sdn    |
|                                   |     Bhd                          |
| 5.  Comfort Rubber Gloves         |                                  |
|     Industries Sdn Bhd            | 31. Purnabina Sdn Bhd            |
|                                   |                                  |
| 6.  Concept Rubber Products Sdn   | 32. Quality Latex Products       |
|     Bhd                           |     Malaysia Sdn Bhd             |
|                                   |                                  |
| 7.  Contract Latex Dippers Sdn    | 33. Riverstone Resources Sdn Bhd |
|     Bhd                           |                                  |
|                                   | 34. Sanchem Corporation Sdn Bhd  |
| 8.  Cranberry (M) Sdn Bhd         |                                  |
|                                   | 35. Seal Polymer Industries Sdn  |
| 9.  FELDA Rubber Products Sdn Bhd |     Bhd                          |
|                                   |                                  |
| 10. Flexitech Sdn Bhd             | 36. Seltom Pacific Sdn Bhd       |
|                                   |                                  |
| 11. GB Industries Sdn Bhd         | 37. Smart Glove Corporation Sdn  |
|                                   |     Bhd                          |
| 12. Glovco (M) Sdn Bhd            |                                  |
|                                   | 38. Sri Johani Sdn Bhd           |
| 13. Guthrie Medicare Products     |                                  |
|     (NS) Sdn Bhd                  | 39. SSN Gloves (M) Sdn Bhd       |
|                                   |                                  |
| 14. Handsafe Products Sdn Bhd     | 40. Super Latex Sdn Bhd          |
|                                   |                                  |
| 15. Hartalega Sdn Bhd             | 41. Supermax Corporation Berhad  |
|                                   |                                  |
| 16. IGA Overseas Sdn Bhd          | 42. Tekmedic (M) Sdn Bhd         |
|                                   |                                  |
| 17. JB Star Sdn Bhd               | 43. Terang Nusa Sdn Bhd          |
|                                   |                                  |
| 18. KL-Kepong Rubber Products Sdn | 44. TG Medical (M) Sdn Bhd       |
|     Bhd                           |                                  |
|                                   | 45. Top Glove Corporation Berhad |
| 19. Koon Seng Sdn Bhd             |                                  |
|                                   | 46. Ultrawin Sdn Bhd             |
| 20. Kossan Latex Industries (M)   |                                  |
|     Sdn Bhd                       | 47. Wear Safe (Malaysia) Sdn Bhd |
|                                   |                                  |
| 21. Latexx Manufacturing Sdn Bhd  | 48. WRP Asia Pacifc Sdn Bhd      |
|                                   |                                  |
| 22. Longcane Industries Sdn Bhd   | 49. WRP Senetimed Sdn Bhd        |
|                                   |                                  |
| 23. MAPA (gloves) Sdn Bhd         | 50. YTY Industry Sdn Bhd         |
|                                   |                                  |
| 24. Marcon Rubber Industry Sdn    | 51. Bonric Sdn Bhd               |
|     Bhd                           |                                  |
|                                   |                                  |
| 25. N.S. Uni-Gloves Sdn Bhd       |                                  |
+-----------------------------------+----------------------------------+