DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS)

K993214 · Wrp Specialty Products Sdn. Bhd. · KGO · Dec 2, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993214
• Device Name: DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING 50 MICROGRAMS OR LESS)
• 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 gloves are intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Sterile, powder-free natural rubber latex surgical glove; intended for use by surgeons and operating room personnel to prevent cross-contamination between healthcare staff and patients. Device acts as a physical barrier to protect surgical wounds. Used in clinical and surgical settings. Performance verified via ASTM D3577-99 standards and FDA 1000 ml watertight testing.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D3577-99 and FDA 1000 ml watertight test requirements. Testing included watertight integrity (AQL 1.5), dimensions (length, palm width, thickness), and physical properties (tensile strength and ultimate elongation before and after aging).

Technological Characteristics

Natural rubber latex surgical glove; powder-free; sterile. Meets ASTM D3577-99 specifications for physical dimensions, tensile strength, and elongation. Barrier protection verified via 1000 ml water leak test. Protein content labeling (50 micrograms or less).

Indications for Use

Indicated for surgeons and/or operating room personnel to protect a surgical wound from contamination. Device is made of natural rubber latex.

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)

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DEC - 2 1999

WRP Specialty Products Sdn Bhd

ATTACHMENT 3

1 1 2 7 1 3 V

K993214

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

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

CONTACT PERSON : S.K.OOI

## 510(k) SUMMARY

- 1. Trade Name : DERMAGRIP POWDER FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CONTENT LABELING) ( D micro pams or less )
- 2. Common Name Surgeon's Gloves :
- 3. Classification Name : Surgeon's Glove

## 4. Substantial Equivalence :

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.

## 5. Description of Device :

Class I natural rubber latex surgeon's glove, 79 KGO, powder free, protein content labeling. It meets all of the requirements of ASTM standard D3577-99.

#### 6. Intended Use of Device :

The gloves are intended to be worn on the hand of healthcare personnel, operating room 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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Image /page/1/Picture/0 description: The image contains the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font, set against a black oval shape. To the right of the logo is the text "WRP Specialty Products Sdn Bhd" in a simple, sans-serif font. There is also a handwritten number "5" in a circle above the logo.

# 7. Summary of Performance Data :

Performance data of gloves to ASTM D 3577-99 and FDA 1000 ml watertight test.

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| TEST | ASTM D 3577-99 | DERMAGRIP Powder Free<br>Latex Surgical Glove, Sterile<br>(Protein Content Labeling) - refer<br>to Attachment 7 of Device Test<br>Report of Compliance |
|------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Watertight (1000 ml) | GI, AQL 1.5 | Pass based on<br>1) Single Sampling Plan, GI,<br>AQL 1.5,<br>2) Multiple Sampling Plan, GII,<br>AQL 2.5 |
| 2. Length (mm)<br>Size | | |
| 5½ | min 245 | 294 |
| 6 | min 265 | 300 |
| 6½ | min 265 | 298 |
| 7 | min 265 | 309 |
| 7½ | min 265 | 291 |
| 8 | min 265 | 308 |
| 8½ | min 265 | 304 |
| 9 | min 265 | 301 |
| 3. Palm Width (mm)<br>Size | | |
| 5½ | $70 \pm 6$ | 72 |
| 6 | $76 \pm 6$ | 77 |
| 6½ | $83 \pm 6$ | 83 |
| 7 | $89 \pm 6$ | 90 |
| 7½ | $95 \pm 6$ | 98 |
| 8 | $102 \pm 6$ | 102 |
| 8½ | $108 \pm 6$ | 108 |
| 9 | $114 \pm 6$ | 114 |
| 4. Single Wall Thickness<br>(mm) | | |
| Finger | min 0.10 | 0.27 |
| Palm | min 0.10 | 0.24 |
| Cuff | min 0.10 | 0.20 |
| TEST | ASTM D 3577-99 | DERMAGRIP Powder Free<br>Latex Surgical Glove, Sterile<br>(Protein Content Labeling) - refer<br>to Attachment 7 of Device Test<br>Report of Compliance |
| 5. Physical Properties | | |
| Before Aging : | | |
| Tensile Strength (MPa) | min 24 | 29.58 |
| Ultimate Elongation (%) | min 750 | 902 |
| Stress at 500% Elongation<br>(MPa) | max 5.5 | 2.95 |
| After Aging : | | |
| Tensile Strength (MPa) | min 18 | 22.92 |
| Ultimate Elongation (%) | min 560 | 902 |

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Image /page/2/Picture/0 description: The image shows the logo for WRP Specialty Products Sdn Bhd. The logo consists of the letters "WRP" in a bold, black font inside of a black oval shape. To the right of the logo is the company name, "WRP Specialty Products Sdn Bhd" in a smaller, sans-serif font. Below the company name is the number "1 1 2 7 · 3 V".

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

The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3577-99.

## 9. Conclusion

This glove exceeds the ASTM D 3577-99 requirements, and also meet FDA requirements for water leak test on pinhole AQL.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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

K993214 Re : Dermagrip Powder-Free Latex Surgical Glove, Trade Name: Sterile (Protein Content Labeling 50 micrograms or less) Regulatory Class: I Product Code: KGO Dated: September 15, 1999 September 24, 1999 Received:

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, 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 Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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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 leqally 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 requlation (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,

Patrícia Cincinato / for

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.

510(k) Number (if known)

DERMAGRIP POWDER FREE LATEX SURGICAL Device Name : GLOVE, STERILE (PROTEIN CONTENT LABELING) (50 micrograms on less)

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

Dina S. Lin

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