LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE

K991158 · P. T. Tata Rubberindo Industries · LYY · May 28, 1999 · General Hospital

Device Facts

• Record ID: K991158
• Device Name: LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE
• Applicant: P. T. Tata Rubberindo Industries
• Product Code: LYY · General Hospital
• Decision Date: May 28, 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

Latex examination gloves; powder-free; disposable. Worn by healthcare examiners on hands or fingers. Function: physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings. Output: physical protection. Benefit: reduced risk of infection transmission.

Clinical Evidence

No clinical data. Bench testing only. Device meets ASTM D 3578 standards for tensile strength, elongation, and FDA pinhole requirements.

Technological Characteristics

Latex material; powder-free. Dimensions: 240 mm length; width varies by size (XS-XL). Thickness: 0.10 mm (cuff, palm, finger tip). Physical properties: 21 MPa tensile strength (before aging), 16 MPa (after aging); 700% ultimate elongation (min).

Indications for Use

Indicated for use as a disposable medical 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.

Predicate Devices

• Class I Latex Examination Gloves 80 LYY (meeting ASTM D 3578-95)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo with the word "TATA" at the bottom. Above the word "TATA" is a symbol that appears to be a person standing with their arms outstretched. Above the person is a semi-circular design with lines radiating upwards, resembling the sun. The logo is black and white.

# PT. TATA RUBBERINDO INDUSTRIES

11 th. Floor WISMA ARGO MANUNGGAI
11 th. Floor WISMA Key, 22 11 th. Floor WiSambroto Kav. 22 Jakarta - 12930

K991158

Factory : Jl. Raya Serang Km. 13.8 . Jl. Raya Select (Hunling) Phone ( 021 ) 5962436
( 021 ) 5962436
Cikupa - Tangerang : Fax.

Page Numbers 1 of 2

## "510 (K)" SUMMARY (K991158)

| (1) Name of applicant<br>Address | : Mr. Andy Tanaka<br>: PT. Tata Rubberindo Industries<br>Jl. Raya Serang Km. 13.8<br>Cikupa - Tangerang<br>Jakarta - Indonesia<br>Phone No. 62-21-5962435<br>Fax No. 62-21-5962436 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The contact persons within the firm as well as in U.S.A are given below: | |
| Contact person in firm | : Mr. Andy Tanaka<br>Fax No. 62-21-5962436 |
| Contact person in U.S.A | : Cindy Tung<br>Fax No. : 626-913-1498 |
| (2) Device details<br>Trade Name<br>Classification Name<br>Product Code | : Latex Examination Gloves - Powder Free<br>: Patient Examination Gloves<br>: Latex 80 LYY |
| (3) Equivalent device legally<br>marketed | : Class I Latex Examination Gloves 80 LYY<br>Powder - Free meeting ASTM D 3578-95 |
| (4) Intended use | : A patient examination glove is a disposable<br>device intended for medical purpose that is worn on<br>the examiner's hand or finger to prevent<br>contamination between and patient examiners. |

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K991158

: : ,

#### (5) Technological characteristic of the gloves.

| a. Dimensions<br>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

| ﮨﮯ ﺍﻭﺭ ﺍﯾﺮﺍﻥ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ<br>1. Cuff (min) | | 0.10 mm 0.10 mm 0.10 mm | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------|--|
| 2. Palm (min) | | | |
| 3. Finger Tip (min) 0.10 mm 0.10 mm 0.10 mm 0.10 mm 0.10 mm | | | |

- b. Physical Properties

| Tensile Strength: | Before aging | After aging<br>at 70°C 168 hrs. |
|----------------------|--------------|---------------------------------|
| | 21 Mpa | 16 Mpa |
| Ultimate Elongation: | 700 % (min.) | 600 % (min.) |

:

1000

- (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.
30

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it.

TUL I a 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PT. Tata Rubberindo Industries C/O Mr. Andy Tanaka Jl. Raya Serang Km. 13.8 Cikupa - Tangerang INDONESIA

K991158 Re: Latex Examination Gloves - Powder Free Trade Name: Regulatory Class: I Product Code: LYY May 12, 1999 Dated: Received. My 14, 1999

Dear Mr. Tanaka:

This letter corrects our substantially equivalent letter of May 28, 1999 regarding the address.

We have reviewed your Section 510(k) notification of intent to
r have and the bling bline for your device on our labeling We have reviewed your Section 510\\\/ hockrice on our labeling
market the device ific advice for your device on our labeling market the device fric advice tor goals and additionally 809.10 for in
regulation (21 CFR Part) plance contact the Office of regulation (21 crk rare over anase contact the Office of vitro diagnostic devices), please concase concasso de compliance on Compliance at [phone]. And one devices that have been
che promotion and advertising of your and the Pedera. the promotion and advertising of your actives of the Pederal
reclassified in accordance with the provisions of the Pederal reclassified in accordance with one from may, therefore, Food, Drug, and Cosmetic Acc (no, a meral controls provisions
market the device, subject to the general controls provisions of the Act The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of include requirements furing practice, labeling, and nevices, good manufacturers misbranding and adulteration.

If your device is classified (see above) into either class II If your device Is classifica (bee assocrited Approval) it may be (Special controls) additional controls. Existing major subject to such addrerenar device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ rederal Regulations, freis as mination assumes compliance with Substancially equivalent active requirements, as set forth in the Good Manufacturing lation (QS) for Medical Devices: Che Quality Oyacem Rogara21 ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . periodic QS inspections, FDA will verify such assumptions.

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Page 2 - Mr. Tanaka

Failure to comply with the GMP regulation may result in railure to comply ... In addition, the Food and Drug regulatory accion. In augublish further announcements concerning your device in the Federal Register. Please note: concerning your device in entere in submission does chis response to your promosou might have under sections 531 not arrect any obrigation your ces under the Electronic through 542 of the net 101 acrises or other Federal laws or regulations .

This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA as described in your 510 (i) please of your device to a legally Finding of Subbeancear oquires in a classification for your marketed predicate active 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 onting draghosere devisor) - Establionally, for questions on Compriance at (301) yertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 2018 11:56 obcainca toll free number [phone] or at [phone] or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely,

Timothy A. Ulatowski

Timot Directo Division of Dental, Infection Control, and General Hospital 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 TATA group logo. The logo features a stylized figure standing with arms outstretched, positioned above the word "TATA". The figure is set against a backdrop of radiating lines, resembling a sunrise or a burst of energy. The logo is black and white.

#### PT TATA RUBBERINDO INDUSTRIES

Floor WISMA ARGO MANUNGGAL Ji. Jend. Gatot Subroto Kav. 22 Jakarta - 12930

02115962436 kupa - Tange

ANNEXURE II

K991158

### INDICATION FOR USE

: Mr. Andy Tanaka Applicant : Latex Patient Examination Gloves Powder Free Device Name Indication for use :

Image /page/4/Picture/8 description: The image shows a black circle on a white background. The circle is solid black, and there are a few small white spots within the circle. The white spots are irregularly shaped and scattered throughout the circle. The background is plain white.

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qlim S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 5 : O(k) Number

Prescription Use (Pcc 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Forms: 1-2-96)

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