DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)

K991044 · Wrp Specialty Products Sdn. Bhd. · LYY · Apr 23, 1999 · General Hospital

Device Facts

• Record ID: K991044
• Device Name: DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Dermagrip powder-free latex examination glove; non-sterile; intended for use by healthcare personnel. Device acts as a physical barrier to prevent cross-contamination between patient and examiner during medical procedures. Manufactured from natural rubber latex. Device is worn on the hand; provides protection against fluids, waste, and environmental contaminants. Performance verified against ASTM D3578-95 standards for watertight integrity, physical dimensions, and tensile strength. Protein content labeled as 50 micrograms or less per gram to address potential latex sensitivity. Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D3578-95 standards. Testing included 1000 ml watertight test (passing AQL 4.0), physical dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before and after aging). Protein content measured via ASTM D5712, confirming levels below 50 micrograms/gram.

Technological Characteristics

Natural rubber latex examination glove; powder-free. Meets ASTM D3578-95 standards. Protein content < 50 micrograms/gram. Watertight integrity verified via 1000 ml test. Tensile strength > 14 MPa (before aging) and > 14 MPa (after aging). Ultimate elongation > 700% (before aging) and > 500% (after aging).

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent 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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4/23/99

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are stacked horizontally, with the "W" on the left, the "R" in the middle, and the "P" on the right. The letters are enclosed within a thick, black, rounded rectangle. The background of the logo is white.

# WRP SPECIALTY PRODUCTS SDN BHD

(Company No: 112713-V)

11, Jalan 2, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia. Fax: [phone] & 846 1482 Tel: [phone] & 846 1486

ATTACHMENT 3

KSS1044

CONTACT PERSON : C. H. KHOO

## 510(k) SUMMARY

- DERMAGRIP POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) 50 micro
- Examination Gloves 2. Common Name :
- 3. Classification Name : Patient Examination Glove

### 4. Substantial Equivalence :

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the reguirements of ASTM standard D3578-95.

## 5. Description of Device :

Class I natural rubber latex patient examination's glove, 80 LYY, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3578-95.

## 6. Intended Use of Device :

The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

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## 7. Summary of Performance Data :

... ...

Performance data of gloves to ASTM D 3578-95 and FDA 1000 ml watertight test.

| TEST | ASTM<br>D3578-95 | DERMAGRIP Powder Free<br>Latex Examination Glove, Non<br>Sterile (Protein Content<br>Labeling) - refer to Attachment<br>9 of Device Test Report of<br>Compliance |
|----------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000<br>ml) | S-4, AQL 4.0 | Pass based on<br>1) Single Sampling Plan, S-4,<br>AQL 4.0,<br>2) Multiple Sampling Plan, GII,<br>AQL 4.0 |
| 2. Length (mm) | | |
| Size | | |
| XS<br>S<br>M<br>L<br>XL | min 220<br>min 220<br>min 230<br>min 230<br>- | 245<br>255<br>297<br>249<br>253 |
| 3. Palm Width (mm) | | |
| Size | | |
| XS<br>S<br>M<br>L<br>XL | 70 ± 10<br>80 ± 10<br>95 ± 10<br>111 ± 10<br>- | 77<br>81<br>96<br>105<br>114 |
| 4. Single Wall Thickness<br>(mm) | | |
| Finger | min 0.08 | 0.36 |
| Palm | min 0.08 | 0.25 |
| TEST | ASTM<br>D3578-95 | DERMAGRIP Powder Free<br>Latex Examination Glove,<br>Non Sterile (Protein Content<br>Labeling) - refer to<br>Attachment 9 of Device Test<br>Report of Compliance |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 14 | 28.63 |
| Ultimate Elongation (%) | min 700 | 962 |
| After Aging : | | |
| Tensile Strength<br>(MPa) | min 14 | 18.43 |
| Ultimate Elongation<br>(%) | min 500 | 1007 |
| 6. Powder Content | - | below 2 mg/glove |
| 7. Protein Content | - | below 50 microgram/gram |

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#### on based _ Assessment of Non-Clinical 8. Substantial Equivalence Performance Data

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-95.

Protein content tested on recently manufactured and accelerated aging gloves using ASTM D5712 is below 50 microgram/gram.

## 9. Conclusion

のお洒落

This glove exceeds the ASTM D3578-95 requirements, meet FDA requirements for waterleak test on pinhole AQL and below 50 microgram/gram protein content labeling claim.

Date Summary Prepared : January 12, 1999.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Cheng Hean Khoo Senior Manager, Regulatory/Environmental Management WRP Specialty Products Sdn. Bhd. Lot 11, Janal 2, Kawasan Perusahaan Bander Baru Salak Tingqi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

Re : K991044 Dermagrip Powder-Free Latex Examination Trade Name: Glove, Non-Sterile (Protein Content Labeling 50 micrograms or less) Requlatory Class: I Product Code: LYY March 26, 1999 Dated: Received: March 30, 1999

Dear Mr. Cheng Hean Khoo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Cheng Hean Khoo

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 2

Applicant : WRP Specialty Products Sdn. Bhd.

144104 510(k) Number (if known) : __

DERMAGRIP POWDER FREE LATEX EXAMINATION Device Name : STERILE (PROTEIN CONTENT NON GLOVE. LABELING) ( 50 micrograms or Less )

Indications For Use :

10:30:00

- The patient examination glove is a disposable device intended for 1. medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use

Chin S. Kim

ivision of Dental, Infection Control. ad Genera! Hospital Devic 510(k) Number