NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING

K014055 · Seal Polymer Industries Bhd. · LYY · Jan 28, 2002 · General Hospital

Device Facts

• Record ID: K014055
• Device Name: NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING
• Applicant: Seal Polymer Industries Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Story

Medical examination glove; worn on hands of healthcare personnel; provides barrier protection against patient body fluids, waste, and environmental contaminants. Manufactured from latex; lightly powdered with absorbable dusting powder. Used in clinical settings to prevent cross-contamination. Performance verified via watertight testing, physical property assessment (tensile strength, elongation), and biocompatibility testing (dermal irritation, sensitization).

Clinical Evidence

Bench testing only. Performance data includes watertight (1000 ml) testing (AQL 2.5%), physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before/after aging). Biocompatibility testing included Primary Dermal Irritation and Guinea Pig Sensitization (Buchler) tests. Powder content verified below 200 mg/glove; protein content verified below 200 micrograms/gram.

Technological Characteristics

Material: Latex. Powdered with absorbable dusting powder. Dimensions: 240 mm minimum length; variable palm widths. Thickness: 0.10 mm minimum. Standards: ASTM D3578-99. Biocompatibility: Passed Primary Dermal Irritation and Guinea Pig Sensitization tests.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

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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## SEAL POLYMER INDUSTRIES S )N. BHD. Lot 72706, Jalan Lahat Krwasan Perindustrian Bukit Merah

31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 32 : 2300

| 1.0 | | SMDA 510 (K) SUMMARY | K014055 |
|-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------|
| 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 CHOO: FONG | |
| | Date of Summary Prepared | November 15, 2001 | |
| 3.0 | Name of Device | | |
| | Trade Name | Cashmere Non-Sterile, Powdered<br>Latex Examination Gloves | |
| | Common Name | Exam Glove | |
| | Classification Name | Powdered Patient Examination<br>Glove | |

#### Identification of the Legally Marketed Devices 4.0

Class 1 Powdered Latex Patient Examination Glove 30 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA requirements.

#### રું.0 Description of The Device

Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.

#### The Intended Use of Glove 6,0

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

> Page 1 of 3 ATTACHMENT I

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SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

### Summary of Performance Data: 7.

.

Performance data of gloves based on ASTM D3578-99 and FDA 1000 ml watertight test.

| TEST | ASTM D3578-99 | CASHMERE LIGHTLY POWDERED LATEX EXAM GLOVES |
|------------------------------------------------------------------|----------------|---------------------------------------------|
| 1. Watertight (1000 ml) | GI<br>AQL=2.5% | Pass GI<br>AQL=2.5% |
| 2. Length (mm)<br>Size XS | Min 230 | 240 mm minimum for all sizes |
| S | Min 230 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | Min 230 | |
| 3. Palm width (mm)<br>Size XS | - | <80 |
| S | 80 +/- 10 | 82 - 88 |
| M | 95 +/- 10 | 92 - 98 |
| L | 111 +/- 10 | 102 - 108 |
| XL | - | >110 |
| 4. Thickness (mm)<br>(Single Layer)<br>Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa) | Min 14 | 27.1* |
| Ultimate Elongation (%) | Min 700 | 917.5* |
| After Aging<br>Tensile Strength (Mpa) | Min 14 | 24.9* |
| Ultimate Elongation (%) | Min 500 | 880* |
| 6. Powder Content | - | Below 200 mg / glove |
| 7. Protein Content | - | Below 200 microgram / gram |

* These figures were the average among the eight tested samples. Please refer to Attachment B2.

Page 2 of 3 ATTACHMENT I

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## SEAL POLYMER INDUSTRIES SDN. BHD. Lot 72706, Jalan Lahat Kawasan Perindustrian Bukit Merah 31500 Lahat, Perak Tel : 605 - 322 3200, Fax : 605 - 322 2300

- The performance data of the glove as showed above meet the ASTM D3578-99 8. Standard and FDA's requirement. Powder content is below 200 mg per glove, which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buchler) test. The gloves pass the Biocompatibility Tests.
- 10. Conclusion

We concluded that the Cashmere Non-Sterile, Lightly Powdered Latex Examination Gloves meet:

- ASTM D3578-99 Standard -
- FDA pinhole requirements =
- . " FDA minimum powder residual content

Page 3 of 3 ATTACHMENT I

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2002

Mr. Chun C. Fong Seal Polymer Industries Sdn. Bhd. Lt 72706, Jalan Lahat, Kawasan Perindustrain Bukit Merah Lahat, Ipoh, Perak, MALAYSIA

Re: K014055

Trade/Device Name: Non-Sterile Powdered Latex Examination Gloves with a Protein Labeling Claim ( 200 Micrograms orLess ) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 4, 2001 Received: December 10, 2001

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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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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy 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

KO14055

: Seal Polymer Industries Sdn. Bhd. Applicant

S 10(K) Number

: Cashmere Non-Sterile, Powdered Latex Examination Device Name Gloves With Protein Labeling Claim (200 micrograms or less)

Indication For Use:

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the parients' body, fluids, waste ﺃﺧﺬ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﺘﻲ

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

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

OR

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

Olin S. Lin
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 1 ((k) Number _

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