ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)

K972616 · Wembley Rubber Products (M) Sdn Bhd · LYY · Jan 27, 1999 · General Hospital

Device Facts

• Record ID: K972616
• Device Name: ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
• Applicant: Wembley Rubber Products (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body , fluids, waste , or environment.

Device Story

Oncology Plus Powder Free Latex Examination Gloves; disposable latex gloves; worn by healthcare personnel. Function: physical barrier to prevent cross-contamination between examiner and chemotherapy agents, patient body fluids, waste, or environment. Operation: manual donning by clinician. Benefit: protection against chemotherapy agents and infectious materials. Device meets ASTM D3578-91 standards for physical properties and watertight integrity.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D3578-91 and FDA 1000 ml watertight test (AQL 1.5). Physical properties (tensile strength, elongation) tested before and after aging. Protein content verified below 50 µg/g using ASTM D5712.

Technological Characteristics

Material: Latex. Powder-free. Standards: ASTM D3578-91 (physical properties, dimensions), ASTM D5712 (protein content). Watertight integrity: FDA 1000 ml test. Protein content: <50 µg/g. Form factor: Disposable examination glove.

Indications for Use

Indicated for use by healthcare personnel as a disposable medical glove to prevent contamination between the examiner and chemotherapy agents, or between the examiner 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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JAN 27 1999

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in bold, black font. The letters are slightly distressed, giving them a textured appearance. The letters are enclosed within a rounded rectangular shape, also in black. The logo has a simple, clean design.

972616

# WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)

l or 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia rketing / QA Tel: [phone] / 1867 Fax: [phone] / 1557 Operations Tel: [phone] / 1496 Fax: [phone] / 1608

CONTACT PERSON : MR. Y. W. CHOW

### 510 (K) SUMMARY

- : ONCOLOGY PLUS POWDER FREE LATEX 1. Trade Name EXAMINATION GLOVES (PROTEIN CONTENT LABEI ING)
- 2. Common Name : Examination Gloves
- 3. Classification Name : Patient Examination Glove

#### 4. Substantial Equivalence :

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

#### 5. Description of device :

Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.

#### 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 chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body , fluids, waste , or environment.

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Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the top half of the circle, and the letters 'OH' are at the bottom. The logo appears to be a stamp or seal, possibly indicating registration or certification of a manufacturer in Ohio.

Image /page/0/Picture/18 description: The image shows a circular logo with the words "REGISTERED FIRM" around the perimeter. Inside the circle is an inverted triangle shape. Above the triangle is a horizontal line with a small square on top of it.

Image /page/0/Picture/19 description: The image shows a black diamond shape with a white stripe across the top. The word "REGISTERED" is printed in black letters on the white stripe. The diamond shape is oriented with one point facing up and one point facing down.

Image /page/0/Picture/20 description: The image shows the CE marking, which consists of the letters 'C' and 'E'. The 'C' is a simple, curved shape, while the 'E' is also curved but with a shorter middle stroke. This marking indicates that a product conforms to health, safety, and environmental protection standards for products sold within the European Economic Area.

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K972616

## 7. Summary of Performance data :

・・ Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.

| TEST | ASTM D 3578-91 | ONCOLOGY PLUS Powder<br>Free Latex Examination<br>Gloves (Protein Content<br>Labeling) |
|-------------------------|----------------|----------------------------------------------------------------------------------------|
| 1.Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | | |
| Size XS | - | - |
| S | min 230 | 295 |
| M | min 230 | 293 |
| L | min 230 | 298 |
| XL | - | - |
| 3. Palm width (mm) | | |
| Size XS | - | - |
| S | $80 \pm 10$ | 83 |
| M | $95 \pm 10$ | 94 |
| L | $111 \pm 10$ | 106 |
| XL | - | - |
| 4. Thickness (mm) | | |
| Finger | min 0.08 | 0.27 |
| Palm | min 0.08 | 0.17 |
| 5. Physical Properties | | |
| Before Ageing : | | |
| Tensile Strength (MPa) | min 21 | 25.48 |
| Ultimate Elongation (%) | min 700 | 856 |
| After Ageing : | | |
| | | |
| Tensile Strength (MPa) | min 16 | 20.81 |
| Ultimate Elongation (%) | min 500 | 969 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |

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## 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 3578-91.

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

#### 9. Conclusion

This glove exceed the ASTM D 3578-91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.

Date Summary Prepared : June 16, 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA

K972616 Re : Oncology Plus Powder-Free Latex Examination Trade Name: Gloves (Protein Content Labeling, (50 Micrograms or Less) Regulatory Class: I Product Code: LYY Dated: November 10, 1998 Received: November 17, 1998

Dear Mr. Chow Yue Wah:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Chow Yue Wah

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 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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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510(k) Number (if known) : __K972614

## Device Name : ONCOLOGY PLUS POWDER FREE LATEX EAMINATION GLOVES (PROTF N CONTENT LABELING) 50) IQ ICECC20105 ON LESS

Indications For Use :

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

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

Clim S. lin

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