← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K020040

# LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM (K020040)

_Pt. Maja Agung Latexindo · LYY · Aug 1, 2002 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K020040

## Device Facts

- **Applicant:** Pt. Maja Agung Latexindo
- **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md)
- **Decision Date:** Aug 1, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

## Device Story

Disposable latex examination glove; powdered with oat starch; intended for use by healthcare professionals to prevent cross-contamination between patient and examiner. Device acts as a physical barrier. Manufactured in various sizes (XS-XL) with specified thickness and tensile strength. Used in clinical settings. Benefits include barrier protection during medical examinations.

## Clinical Evidence

No clinical data; bench testing only. Device meets ASTM D 3578-01 standards for dimensions, physical properties (tensile strength, elongation), and freedom from holes. Sterility assurance level and protein content labeling claims (50µg or less) verified via non-clinical testing.

## Technological Characteristics

Latex examination glove; powdered with oat starch. Dimensions: 240mm length; 0.10mm minimum thickness (cuff, palm, finger). Physical properties: 14 MPa (min) tensile strength; 650% (min) ultimate elongation. Meets ASTM D 3578-01 standards. Sterilized.

## Regulatory 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 Examination Gloves 80 LYY meeting ASTM D 3578-01

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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AUG 0 1 2002

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Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

Telp. 62-61 - 8459160 62-61 - 8459170 62-61 - 8459180 Fax.

## "510 (K)" SUMMARY K020040

( 1 ) Name of applicant: Address:

Mr. Hansen Laurence PT. MAJA AGUNG LATEXINDO Jl. Utama No. 98 Puji Mulyo Sunggal - Deli Serdang North Sumatra - Indonesia Phonc No. : (62-61) 845-9170 Fax No. 1 : (62-61) 845-9180

The contact persons within the firm as well as in U.S.A are given below: Contact person in firm: Mr. Hansen Laurence Fax No .: (62-61) 845-9180 Contact person in U.S.A: Emmy Tjoeng Fax No .: (909) 591-8878

(2) Device details Trade Name: Latex Examination Gloves powdered with Oat Starch with protein content labeling claim (50ug or less)

Classification Name: Patient Examination Gloves Powdered

(3) Product Code: 80 LYY

(4) Equivalent device legally marketed: Class I Examination Gloves 80 LYY meeting ASTM D 3578-01

(5) Intended use: Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

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K. 2664

# K020040

# (6) Technological characteristic of the gloves.

| a. Dimensions    |          |           |           |            |           |
|------------------|----------|-----------|-----------|------------|-----------|
| Sizes            | XS       | S         | M         | L          | XL        |
| Length mm (min.) | 240      | 240       | 240       | 240        | 240       |
| Palm Width mm    | $75\pm5$ | $80\pm10$ | $95\pm10$ | $105\pm10$ | $115\pm5$ |
| Thickness        |          |           |           |            |           |
| 1. Cuff mm (min) | 0.10     | 0.10      | 0.10      | 0.10       | 0.10      |
| 2. Palm mm(min)  | 0.10     | 0.10      | 0.10      | 0.10       | 0.10      |
| 3. Finger Tip mm | 0.10     | 0.10      | 0.10      | 0.10       | 0.10      |

### b. . Phisycal properties

|                       | Before ageing | After ageing                     |
|-----------------------|---------------|----------------------------------|
| Tensile Strength :    | 14 Mpa (min.) | at 70°C 168 hrs<br>14 Mpa (min.) |
| Ultimate Elongation : | 650 % (min.)  | 500 % (min.)                     |

### c. Performance requirement

| Characteristic                      | Related Defects                      | Inspection<br>Level | AQL |
|-------------------------------------|--------------------------------------|---------------------|-----|
| Sterility                           | Fails sterility                      | A                   | N/A |
| Freedom from holes                  | Holes                                | 1                   | 2.5 |
| Dimensions<br>& Thickness           | Width Length                         | S-2                 | 4   |
| Physical Properties<br>after ageing | Before and                           | S-2                 | 4   |
| Powder Free Residue                 | Exceeds Maximum Limit                | N=5                 | N/A |
| Protein Content                     | Exceeds Recommended<br>Maximum Limit | N=3                 | N/A |
| Powder Amount                       | Exceeds Recommended<br>Maximum Limit | N=2                 | N/A |

- (7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.

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K020040

(9) Non-clinical data We certify that the gloves meet or exceed the ASTM D 3578-01 Standard. Meets FDA pinhole requirement. Meets labeling claim. Meets the sterility assurance level.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 0 1 2002

PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Shamrock Marketing Company, Incorporated 5445 Daniel Street Chino, California 91710

Re: K020040

Trade/Device Name: Latex Pre-powdered (Oat Starch) Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: May 6, 2002 Received: July 2, 2002

Dear Ms. Tjoeng:

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. Tjoeng

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/5/Picture/0 description: The image shows a close-up of a symbol or logo, possibly handwritten, against a background of horizontal lines. The symbol appears to be stylized letters, possibly 'Ma', with a flowing, connected script. The background lines add a textured effect, and the symbol is framed by a dark, solid border on the left and bottom.

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

Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

K020040

Applicant: Device Name: PT. Maja Agung Latexindo Latex Examination Gloves powdered with Oat Starch with Protein Content Labeling Claim (50 µg or less)

Indication for use:

Prepowdered latex examination glove is a disposable device intended for medical purpose Frepowdered fatex examiner's hand 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)

Chia S. Lin

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K020040](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K020040)

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