NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE

K992177 · Pt. Berlian Glovindo · LZA · Jul 29, 1999 · General Hospital

Device Facts

• Record ID: K992177
• Device Name: NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
• Applicant: Pt. Berlian Glovindo
• Product Code: LZA · General Hospital
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

Device Story

Nitrile examination gloves; disposable; worn on examiner's hand or finger; barrier protection to prevent cross-contamination between patient and examiner; used in clinical settings; manual operation by healthcare personnel.

Clinical Evidence

No clinical data. Bench testing only; device meets ASTM D 3578 standards and FDA pinhole requirements.

Technological Characteristics

Nitrile material; powder-free; dimensions: 240mm length, 0.10mm minimum thickness (cuff, palm, finger); tensile strength 14 MPa (min); ultimate elongation 700% (min) before aging; meets ASTM D 3578 standards.

Indications for Use

Indicated for use as a disposable medical device 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.

Predicate Devices

• Class I Nitrile Examination Gloves 80 LZA (Pre-powdered meeting ASTM D 3578-95)

Submission Summary (Full Text)

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JUL 29 1999

.jp

# PT. BERLIAN GLOVINDO

JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : [phone] Tel : [phone] Fax :[phone]

Page Numbers 1 of 2

| "510 (K)" SUMMARY<br>K992177 | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (1) Name of applicant<br>Address | : Mr. Tony Jap<br>: PT. Berlian Glovindo<br>Jl. Sutomo Ujung No. 96<br>Medan<br>Indonesia<br>Phone No. 62-61-616944 62-4-92777<br>Fax No. 62-61-8459180 |
| The contact persons within the firm as well as in U.S.A are given below:<br>Contact person in firm | : Mr. Tony Jap<br>Fax No.: 62-61-8459170 |
| Contact person in U.S.A | : Emmy Tjoeng<br>Fax No.: 626-913-1498 |
| (2) Device details<br>Trade Name<br>Classification Name<br>Product Code | : Private lebel-Nirile Examination Gloves Powder Free<br>: Patient Examination Gloves<br>: Nitrile 80 LZA |
| (3) Equivalent device legally<br>marketed | : Class I Nitrile Examination Gloves 80 LZA<br>Pre-powdered meeting ASTM D 3578-95 |
| (4) Intended use | : A patient examination glove is a disposable device<br>intended for medical purpose that is worn on the examiner's<br>hand or finger to prevent contamination between and<br>patient examiners |

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## BERLIAN GLOVINDO

#### JLN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA

Tel : [phone] Tel : [phone] Fax :[phone]

Page Numbers 2 of 2

- (5) Technological characteristic of the gloves.
::::

| Sizes | XS | S | M | L | XL |
|----------------------------|---------|----------|----------|-----------|---------|
| Length | 240 mm | 240 mm | 240 mm | 240 mm | 240 mm |
| Width | 80 < mm | 80±10 mm | 95±10 mm | 111±10 mm | >111mm |
| Thickness<br>1. Cuff (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 2. Palm (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |
| 3. Finger Tip (min) | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm | 0.10 mm |

- b. Physical Properties

| | Before aging | After aging<br>at 100°C 22 hrs. |
|---------------------|---------------|---------------------------------|
| Tensile Strength | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation | 700 % (min.) | 500 % (min.) |

- (6) Performance data is the same as mentioned immediately above.
- (7) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (8) Non-clinical data We certify that these gloves meet ASTM D 3578 Standard. Meets FDA pinhole requirement. Meets labeling claim.

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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Mr. Tony Jap PT. Berlian Glovindo Jln. Raya Medan Rantau Prapat Km +230 Desa Damuli Kec. Labuhan Batu - North Sumatra INDONESIA

Re: K992177 Nitrile Examination Gloves - Pre-Powdered, Trade Name: Small, Medium, and Large Requlatory Class: I Product Code: LZA June 25, 1999 Dated: Received: June 28, 1999

Dear Mr. Jap:

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, Druq, 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. ರ್ಗ 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 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.

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Page 2 - Mr. Jap

this response to your premarket notification Please note: 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 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 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 (800) 638-204g 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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### 1

ILN. SUTOMO UJUNG 96 MEDAN 20235 - INDONESIA Tel : [phone] Tel : [phone] Fax :[phone]

### ANNEXURE II

### INDICATION FOR USE

Applicant

: Mr. Tony Jap

Device Name

: Nitrile Patient Examination Gloves Pre-powdered

Indication for use

K992177

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.

Qais S. Làn

(Division St Division of Dental, Int and General Hospi r 1 Olk) Number