DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE

K993215 · Wrp Specialty Products Sdn. Bhd. · KGO · Dec 2, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993215
• Device Name: DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
• Applicant: Wrp Specialty Products Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Story

Natural rubber latex surgeon's glove; powdered with absorbable dusting powder; worn by surgeons and operating room personnel; provides barrier protection for surgical wounds against contamination; used in clinical/surgical settings; sterile; single-use.

Clinical Evidence

Bench testing only. Compliance with ASTM D3577-99 (Standard Specification for Rubber Surgical Gloves) and ASTM D412-87 (Standard Test Methods for Rubber Properties in Tension). Testing includes tensile strength (min 24 MPa before aging, 18 MPa after), ultimate elongation (min 750% before, 560% after), and stress at 500% elongation (max 5.5 MPa).

Technological Characteristics

Natural rubber latex; powdered with absorbable dusting powder; sterile; meets ASTM D3577-99; physical properties tested per ASTM D412; sampling per ISO 2859/ANSI/ASQC Z1.4; gamma radiation sterilization.

Indications for Use

Indicated for use by surgeons and operating room personnel to protect surgical wounds from contamination during procedures.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

{0}------------------------------------------------

DFC - 2 1999

Image /page/0/Picture/4 description: The image shows the logo for WRP. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters in white and set against a black, rounded rectangle. To the right of the logo is the text "WRP Spec" in a similar font, but without the black background. The text is also in black.

0

WRP Specialty Products Sdn Bhd

になると、とて

Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSIA

TEL [phone] FAX [phone] URL www.wrpwarld.com

ATTACHMENT 3

K 9932215

## CONTACT PERSON : S.K.OOI

## 510(k) SUMMARY

- DERMAGRIP POWDERED LATEX SURGICAL 1. Trade Name : GLOVE, STERILE
- Surgeon's Gloves Common Name 2. :
- Classification Name Surgeon's Glove 3. :

#### 4. Substantial Equivalence :

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

## 5. Description of Device :

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

## 6. Intended Use of Device :

The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Gloves For All Reasons™

mber of the WRP Group of Companies

{1}------------------------------------------------

### SUMMARIZED PROCEDURE OF THE QUALITY ASSURANCE METHODS 2. FOR SURGICAL GLOVES

- (2) REFERENCE 2.1
K 993215

- a) ASTM D 3577-99 Standard Specification for Rubber SURGICAL Gloves.
- b) ASTM D 412-87 Standard Test Methods for Rubber Properties in Tension.
- Sampling Procedures and Tables for Inspection by c) ISO 2859 Attributes.
- d) ANSI/ASQC Z1.4-1993 Sampling Procedures and Tables for Inspection by Attributes.

#### 2.2 SAMPLING

The gloves are sampled at random from a batch, where every part has an equal chance of being selected. The samples are selected and inspected in accordance with ISO 2859/ ANSI/ASQC Z1.4.

#### TEST METHODS 2.3

#### 2.3.1 Physical Requirement Test

- a) The tensile physical properties are determined as described in ASTM D412 using Type C dumb bell test pieces. Test pieces are evaluated to conform to physical requirement on before and after accelerated aging.
- b) The accelerated aging is conducted by subjecting the test piece to a temperature of 100 ℃ ± 2 ℃ for 22 ± 0.3 hours.

### c) Quality Requirement

| | Before Aging | After Aging |
|------------------------------|--------------|----------------|
| Tensile Strength | Min 24 Mpa | Min 18 MPa |
| Ultimate<br>Elongation | Min 750 % | Min 560 % |
| Stress at 500%<br>Elongation | Max 5.5 Mpa | Not Applicable |

- d) The inspection level : ANSI/ASQC Z1.4, (S-2)

| Batch Size | : 300 000 pairs (based on one consignment quantity) |
|-------------|-----------------------------------------------------|
| Sample Size | : 13 pcs |
| AQL | : 4.0 |
| Accept | : 1 pc |
| Reject | : 2 pcs |

{2}------------------------------------------------

# ুমি

Finished Powdered Gloves :

િ

Average Powder Weights on Size 7 ½ Surgical Gloves

| WRP Specialty Products Sdn.<br>Bhd. | SIZE 7½ ACTUAL | POWDER WEIGHT* |
|-------------------------------------|----------------|----------------|
| | (%) | mg/glove |
| Internal : 0.5 -1.5% | 1.41 | 204.7 |
| External (Max) : 1.0% | 0.96 | 140.0 |

Average over eight (8) pieces.

## ATTACHMENTS

| Number | Attached? | Subject |
|--------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | (/) Yes () No | Truthful & Accurate Statement |
| 2. | (/) Yes () No | Indications for Use Statement |
| 3. | (/) Yes () No | 510(k) Summary |
| 4. | (/) Yes () No | Summary of Quality Assurance Testing<br>Procedure of Dermagrip Powdered Latex<br>Surgical Glove, Sterile |
| 5. | (/) Yes () No | Label, Labeling and Advertising |
| 6. | (/) Yes () No | Biocompability Test Reports |
| 7. | (/) Yes () No | Device Test Report of Compliance of<br>Dermagrip Powdered Latex Surgical Glove,<br>Sterile according to ASTM D3577-99 and FDA<br>watertight test requirements. |
| 8. | (/) Yes () No | Validation on Gamma Radiation Sterilization<br>Cycle. |
| 9. | (/) Yes () No | Packaging Use to Maintain the Sterility of the<br>Gloves. |
| 10. | (/) Yes () No | Absorbable Dusting Powder Specification. |
| 11. | (/) Yes () No | Summary of Glove Physical Properties (refer to<br>Attachment 7, Device Test Report of<br>Compliance). |
| 12. | () Yes (/) No | Non-USP Powder Information |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human profile with three overlapping faces, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image, emphasizing the organization's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and public service.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Mr. Soo Kang Ooi Manager, Regulatory Affairs/Quality Assurance WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia

Re : K993215 Powdered Latex Surgical Glove, Sterile Trade Name: Regulatory Class: I Product Code: KGO September 15, 1999 Dated: Received: September 24, 1999

Dear Mr. Ooi:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

{4}------------------------------------------------

Page 2 - Mr. Ooi

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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,

Patricia Cucurella /loc

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

Enclosure

{5}------------------------------------------------

## ATTACHMENT 2

Applicant : WRP Specialty Products Sdn. Bhd.

510(k) Number (if known) :

#### DERMAGRIP POWDERED LATEX SURGICAL GLOVE, Device Name : STERILE

Indications For Use :

- The surgeon's glove is a device made of natural rubber intended to be worn by 1. surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

Olin S. Lin

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