GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR

K032007 · Pt. Wrp Buana Multicorpora · LYY · Jul 28, 2003 · General Hospital

Device Facts

• Record ID: K032007
• Device Name: GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR
• Applicant: Pt. Wrp Buana Multicorpora
• Product Code: LYY · General Hospital
• Decision Date: Jul 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable natural rubber latex examination gloves; worn on examiner's hand or finger; intended to prevent cross-contamination between patient and examiner in medical settings. Device acts as a physical barrier. No electronic or software components.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against ASTM D 3578-01a standards for physical properties, dimensions, and pinhole AQL, and ASTM D 5712-99 for protein content.

Technological Characteristics

Natural rubber latex; powder-free; blue color; non-sterile. Meets ASTM D 3578-01a standards for dimensions and physical properties. Protein content <50 µg/g (ASTM D 5712-99). Powder residue <2 mg/glove (ASTM D 6124-01). Biocompatibility confirmed via primary skin irritation and dermal sensitization testing.

Indications for Use

Indicated for use as a disposable, non-sterile, natural rubber latex glove worn on the examiner's hand or finger to prevent cross-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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JUL 2 8 2003

Image /page/0/Picture/1 description: The image shows a logo with the letters "WRP" in white against a black background. The letters are bold and slightly stylized, with the "W" and "R" connected at the top. To the right of the logo, there is a partial letter "P" in black, suggesting that there may be more text or another element that is cut off in the image.

P Buana Multicorpora

KO3 2007

Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

Tel [phone] [phone] Fax [phone] URL www.wrpworld.com

# 510 (K) SUMMARY

#### 1.0 Submitter :

| Name | : PT. WRP Buana Multicorpora |
|-----------|--------------------------------------------------------------------------|
| Address | : Jl. Jermal No.20B Kelurahan Sei Mati<br>Medan Labuhan KM 17, INDONESIA |
| Phone No. | : [phone], 6942462 |
| Fax No. | : [phone] |

Date of Summary Prepared : June 9 , 2003

#### 2.0 Contact Person :

| Name | :Mr. Ng Poy Sin |
|-----------|-----------------------|
| Phone No. | :[phone], 6942462 |
| Fax No. | :[phone] |

#### Name of the device : 3.0

| Trade Name | 1). Glovetex, and<br>2). Multiple or Customers' Trade Name |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Powder Free Latex Examination Gloves, Blue, Non-Sterile<br>Contains 50 micrograms or less of Total Water Extractable Protein per gram |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class I) |

#### Identification of The Legally Marketed Device : 4.0

Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 -- 01a22 and FDA 1000 ml Water Leak Test.

#### 5.0 Description of The Device :

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

#### 6.0 Intended Use of the Device :

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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Image /page/1/Picture/0 description: The image shows the logo for "PT. WRP Buana Multicorpora". The logo consists of the letters "WRP" in a stylized, bold font, enclosed in a black shape. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font.

Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17. INDONESIA

Tel + 62-61-6942461 [phone] Fax [phone] URL www.wrpworld.com

#### 7.0 Summary of The Technological Characteristics of The Device :

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|----------------------------------|---------------------------------------|----------------------------------------|
| Dimensions | D 3578 - 01aᵉ² | Meets |
| Physical Properties | D 3578 - 01aᵉ² | Meets |
| Freedom from Pinholes | D 3578 - 01aᵉ²<br>FDA 21 CFR 800.20 | Meets |
| Powder Residue | D 3578 - 01aᵉ²<br>D 6124 - 01 | < 2 mg/glove |
| Water Soluble Protein<br>Content | D 3578 - 01aᵉ²<br>D 5712 - 99 | < 50 µg/g |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(No primary skin irritation) |
| | Dermal Sensitization | Passes<br>(No contact sensitizer) |

#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

#### 9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### 10.0 Conclusion

It can be concluded that the Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is black and is surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 8 2003

Ng Poy Sin President Director PT. WRP Buana Multicorpora Jalan Jermal #20-B, Kelurahan, Sei Mati, Madan- Labuhan Km 17, INDONESIA

Re: K032007

Trade/Device Name: Glovetex Powder Free Latex Examination Gloves Blue, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 12, 2003 Received: June 30, 2003

Dear Mr. Sin:

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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Page 2 - Mr. Sin

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Paltace Cuerite/ba

Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for PT. WRP Buana Multicorpora. The logo consists of the letters "WRP" in a stylized font inside of a black oval shape. To the right of the logo is the text "PT. WRP Buana Multicorpora" in a bold, sans-serif font.

Jalan Jermal No. 20-B, Kelurahan Sei Mati, Medan-Labuhan Km 17, INDONESIA

+ 62-61-6942461 Tel [phone] Fax [phone] URL www.wrpworld.com

### INDICATIONS FOR USE

| Applicant | : PT. WRP Buana Multicorpora |
|--------------------------|------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | : K032002 |
| Device Name | : POWDER FREE LATEX EXAMINATION GLOVES,<br>BLUE, NON STERILE. (Contains 50 micrograms or |

Indications For Use:

Powder Free Latex Examination Gloves, Blue, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

less of Total Water Extractable Protein per gram)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032007

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter _