POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K982897 · Pt. Maja Agung Latexindo · LYY · Dec 23, 1998 · General Hospital

Device Facts

• Record ID: K982897
• Device Name: POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
• Applicant: Pt. Maja Agung Latexindo
• Product Code: LYY · General Hospital
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for 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; designed to reduce protein content to 50 micrograms or less. Used in clinical settings by healthcare professionals to provide a protective barrier between examiner and patient. Manufactured from natural rubber latex with chemical additives (zinc oxide, sulfur, BHT, etc.). Device acts as a physical barrier to prevent contamination. Performance verified through watertight testing, tensile strength, and elongation measurements. Intended for single-use applications.

Clinical Evidence

No clinical data. Bench testing only. Device meets ASTM D 3578-95 standards for physical properties (tensile strength, elongation), dimensions, and watertightness (AQL 2.5). Residual powder content and protein extractable levels (max 50 microgram/gram) were verified.

Technological Characteristics

Natural rubber latex examination gloves. Materials: 60% concentrated natural rubber latex, KOH, zinc diethyl/dibutyl dithiocarbamate, zinc oxide, sulfur, titanium dioxide, BHT. Dimensions: 240 mm length, 0.10 mm minimum thickness at cuff, palm, and fingertip. Physical properties: 21 MPa tensile strength (before aging), 700% ultimate elongation (before aging). Complies with ASTM D 3578-95. Powder-free. Protein content ≤ 50 micrograms/gram.

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 Latex Examination Gloves 80 LYY (meeting ASTM D 3578 – 95)

Submission Summary (Full Text)

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DEC 23 398

Image /page/0/Picture/1 description: The image shows a stylized logo or design featuring the letters "ma" in a cursive or handwritten style. The letters are positioned above a thick, black horizontal bar. Above the letters, there are several horizontal lines that create a striped effect. The overall design is simple and graphic, with a focus on the contrast between the black elements and the white background.

## K 982897 PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180

Page Numbers 1 of 2

### "510 (K)" SUMMARY

| (1) Name of applicant<br>Address | : Mr. Hansen Laurence<br>: PT. MAJA AGUNG LATEXINDO<br>Jl. H. Yamin No. 40 – 40 A<br>Medan 20234<br>Indonesia<br>Phone No.<br>Fax No. | : 62-61-328888 ; 62-61-859170<br>: 62-61-520588 ; 62-61-520588 |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The contact persons within the firm as well as in U.S.A are given below: | | |
| Contact person in firm | : Mr. Hansen Laurence<br>Fax No. | : 62-61-520588 ; 62-61-859170 |
| Contact person in U.S.A | : Emmy Tjoeng<br>Fax No. | : 562-693-8866 |
| (2) Device details | | |
| Trade Name | | : Latex Examination Gloves<br>Powder Free with Protein Claim |
| Classification Name | | : Patient Examination Gloves |
| Product Code | | : Latex 80 LYY |
| (1) Equivalent device legally<br>marketed | | : Class I Latex Examination Gloves 80 LYY<br>Powder Free with Protein Claim<br>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 examiner's<br>hand or finger to prevent contamination between patient<br>and examiners |

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Kg82897

Image /page/1/Picture/1 description: The image shows a logo with the letters "Ma" in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The left side of the logo has a solid black shape, possibly a square or rectangle, that partially obscures the background lines.

### PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

62-61 - 859160 Telp. 62-61 - 859170 Fax. 62-61 - 859180

Jin. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

Page Numbers 2 of 2

| (5) Technological characteristic of the gloves. | | | | |
|-------------------------------------------------|------------------------------------------------------------------|--------------------------|------------------|-------------------------------|
| a. Dimensions | | | | |
| Sizes | | Small | Medium | Large |
| Length (min.) | | 240 mm | 240 mm | 240 mm |
| Palm Width thickness | | 85±10 mm | 95±10 mm | 111±10 mm |
| 1. Cuff (min) | | 0.10 mm | 0.10 mm | 0.10 mm |
| 2. Palm (min) | | 0.10 mm | 0.10 mm | 0.10 mm |
| 3. Finger Tip (min) | | 0.10 mm | 0.10 mm | 0.10 mm |
| b. Physical Properties | | | | |
| | | | Before ageing | After ageing at 70°C 168 hrs. |
| Tensile Strength | : | | 21 Mpa | 16 Mpa |
| Ultimate Elongation | : | | 700 % (min.) | 600 % (min.) |
| c. Performance Requirement | | | | |
| Characteristic | | Related Defects | Inspection Level | AQL |
| Watertight | | Holes | S-4 | 2.5 |
| Dimensions | | Width Length & Thickness | S-2 | 4 |
| Physical Properties | | Before and after ageing | S-2 | 4 |
| d. | Weight of residual powder in medium size gloves : 0.50 ± 0.20 mg | | | |
| e. | Total water extractable protein 50 microgram/gram (maximum) | | | |
| f. | Bio-Compatibility (attached) | | | Annexure XII |
| g. | Test Results as per ASTM D 3578 - 95 (attached) | | | Annexure V |

- (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 Gloves meet or exceed the ASTM Standard. Meets FAD pin hole requirement. Meets labeling claim.

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K 4782897

#### MATERIALS USED FOR THE PRODUCTION OF LATEX EXAMINATION GLOVES POWDER - FREE WITH PROTEIN CLAIM

| | Dry Weight |
|----------------------------------------|------------|
| 60 % Concentrated Natural Rubber Latex | - 100 |
| KOH Solution | - 0.10 |
| Zinc diethyl dithiocarbamate | - 0.50 |
| Zinc dibutyl dithiocarbamate | - 0.30 |
| Zinc oxide | - 0.75 |
| Sulphur | - 0.80 |
| Titanium dioxide | - 0.60 |
| BHT | - 1.50 |

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EE 2 3 1936

P.T. Maja Agung Latexindo C/O Ms. Emmy Tjoenq Official Correspondent Glove Source, Incorporated 345 Cloverleaf Drive, Suite B Baldwin Park, California 91706

Re : K982897 Powder-Free Latex Examination Glove with Trade Name: Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY November 25, 1998 Dated: November 27, 1998 Received:

Dear Ms. Tjoeng:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ 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 regulation 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 - Ms. Tjoeng

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 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"(21CFR 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/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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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Image /page/5/Picture/0 description: The image shows a logo with the letters 'ma' in a stylized font. The letters are overlapping and appear to be drawn with thick lines. The background behind the letters consists of horizontal lines, creating a striped effect. The bottom portion of the image is a solid black rectangle, providing a base for the logo.

# PT. MAJA AGUNG LATI

MANUFACTURING OF LATEX GLOV

Jin. Utama No. 98 PUJi MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

62-61 - 85916 Telp. 62-61 - 8591. Fax. 62-61 - 8591

#### ANNEXURE II

#### INDICATION FOR USE

| Applicant | : Mr. Hansen Laurence |
|--------------------|-------------------------------------------------------------|
| Device Name | : Latex Patient Examination Gloves Powder Free With Protein |
| Indication for use | : Content Labeling Claim ( 50 micrograms or less ) |

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)

S. Barrett for Ckn

(Division Sign-Off) Division of Death, infection . Satrol, and General Hospital Devices 510(k) Number .

Prescription Use ( Per 21 CFR 801. 109 ) OR

Over-The-Counter Use

( Optional Format 1-2-96 )