CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM

K021388 · Seal Polymer Industries Bhd. · LYY · Jun 10, 2002 · General Hospital

Device Facts

• Record ID: K021388
• Device Name: CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
• Applicant: Seal Polymer Industries Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable patient examination glove; latex material; polymer coated; powder-free. Worn by healthcare professionals on hands or fingers during medical examinations. Acts as a physical barrier to prevent cross-contamination between patient and examiner. Device meets ASTM D3578-00a standards for watertight integrity, physical dimensions, and tensile strength. Biocompatibility confirmed via primary dermal irritation and guinea pig sensitization tests. Protein content labeled at 50 micrograms or less per gram.

Clinical Evidence

Bench testing only. Performance data includes watertight (1000 ml) testing (AQL 4.0%), physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before and after aging). Biocompatibility testing included primary dermal irritation and Guinea Pig Sensitization (Buehler) tests. All results met ASTM D3578-00a and FDA requirements.

Technological Characteristics

Material: Latex; polymer coated. Form factor: Disposable examination glove. Standards: ASTM D3578-00a. Physical properties: Tensile strength >14 MPa (before/after aging), elongation >650% (before aging). Powder content: <2 mg/glove. Protein content: <50 micrograms/gram. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hands or fingers to prevent cross-contamination between patient and examiner.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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# JUN 1 0 2002

K024 388

### SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: [phone] Fax: [phone] E-mail: [e-mail]

| 1.0 | | SMDA 510 (K) SUMMARY |
|-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 2.0 | Submitter | SEAL POLYMER INDUSTRIES SDN BHD<br>Lot 72706, Jalan Lahat<br>Kawasan Perindustrian Bukit Merah<br>31500 Lahat, Perak, Malaysia |
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Ms. CHUN CHOOI FONG |
| | Date of Summary Prepared | March 27, 2002 |
| 3.0 | Name of Device | |
| | Trade Name | Cashmere Powder Free Latex Examination Gloves |
| | Common Name | Exam Glove |
| | Classification Name | Patient Examination Glove |

#### 4.0 Identification of The Legally Marketed Devices

Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA requirements.

#### 5.0 Description of The Device

Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA Water Leak Test.

#### 6.0 The Intended Use of Glove

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

> Page 1 of 3 ATTACHMENT M

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### SEAL POLYMER INDUSTRIES SDN. BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### Summary of Performance Data : 7.

Performance data of gloves based on ASTM D3578-00a and FDA 1000 ml watertight test.

| TEST | ASTM D3578-00a | CASHMERE POWDER<br>FREE LATEX EXAM<br>GLOVES |
|----------------------------------------|----------------|----------------------------------------------|
| 1. Watertight (1000 ml) | GI<br>AQL=4.0% | Pass GI<br>AQL=4.0% |
| 2. Length (mm)<br>Size XS | Min 230 | 240 mm minimum for<br>all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)<br>Size XS | - | 75 - 78 |
| S | 80 +/- 10 | 82 - 88 |
| M | 95 +/- 10 | 92 - 98 |
| L | 111 +/- 10 | 102 - 108 |
| XL | - | 111 - 115 |
| 4. Thickness (mm)<br>(Single Layer) | | |
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties | | |
| Before Aging<br>Tensile Strength (Mpa) | Min 14 | 25.1 |
| Ultimate Elongation (%) | Min 650 | 940 |
| After Aging<br>Tensile Strength (Mpa) | Min 14 | 18 |
| Ultimate Elongation (%) | Min 500 | 950 |
| 6. Powder Content | - | Below 2 mg / glove |
| 7. Protein Content | - | Below 50 microgram / gram |

Page 2 of 3 ATTACHMENT M

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### SEAL POLYMER INDUSTRIES SDN, BHD.

Lot 72706, Jalan lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak Malaysia. Tel: [phone] Fax: [phone] E-mail: [e-mail]

- 8. The performance data of the glove as showed above meet the ASTM D3578-00a Standard and FDA's requirement. Powder content is below 2 mg per glove that meets the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- 10. Conclusion

We concluded that the Cashmere Powder Free Latex Examination Gloves meet:

- -ASTM D3578-00a Standard
- FDA pinhole requirements r
- FDA minimum powder residual content -

Page 3 of 3 ATTACHMENT M

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

JUN 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chun Chooi Fong Quality Assurance Manager Seal Polymer Industrial Sdn. Bhd. Lot 72706. Jalan Lahat, Kawasan Perindustrian Bukit Merah Lahat, Perak, MALAYSIA 31500

Re: K021388

Trade/Device Name: Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 30, 2002 Received: June 5, 2002

Dear Mr. Fong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Fong

Please be advised that FDA's issuance of a substantial equivalence determination does not . mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timot A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT

Applicant : Seal Polymer Industries Sdn. Bhd.

510(K) Number: K021388

- Device Name : Cashmere Powder Free Latex Examination Gloves With Protein Labeling Claim (50 micrograms or less) & Total Unter Extress & Later & Claim
Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODC)

Prescription Use: ... ... ... ... ... .................. Per 21 CFR 80.109

OR

Over-The-Counter ... ....................

Qia S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _