LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED

K981975 · Siam Sempermed Corp., Ltd. · LYY · Nov 20, 1998 · General Hospital

Device Facts

• Record ID: K981975
• Device Name: LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 20, 1998
• 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 purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable latex patient examination glove; blue color; polymer coated. Worn on hand or finger by healthcare personnel; prevents cross-contamination between patient and examiner. Manufactured via latex dipping; surface treated with polymer coating, halogenation, and siliconization; washed to ensure powder-free status. Meets ASTM D3578-95 standards for physical properties and dimensions. Used in clinical settings for barrier protection.

Clinical Evidence

Bench testing only. Device evaluated against ASTM D3578-95 standards for dimensions, physical properties (tensile strength, elongation at break before/after aging), water extractable protein, powder levels, and freedom from holes (AQL 1.5).

Technological Characteristics

Latex material; polymer coated; halogenated/siliconized; powder-free. Dimensions: 240+/-10 mm length; 0.08 mm min thickness. Physical properties: 14 MPa min tensile strength; 700% min elongation (before aging). Complies with ASTM D3578-95.

Indications for Use

Indicated for use by healthcare and similar personnel to prevent contamination between the personnel and the patient.

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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Siam Sempermed D Corporation , Ltd

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# 510(k) SUMMARY 01.11.1997

NOV 20 1998

#### · 0 APPLICANT:

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION. Ltd. 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: [phone] OR 291 649 FAX: [phone]

#### 2.0 CONTACT PERSON

Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION.,Ltd 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: [phone] OR 291 649 FAX: [phone]

#### MR DON MORRIS SATARI CORP.,Ltd 30798 US Hwy 19 N Palm Harbor USA FL 34684 TEL: [phone] OR 800 366 9545 FAX: [phone]

- 3.0 Device Class: I Product code: 80LYY
4.0 Specification: Latex patient examination glove powderfree -Class I 80LYY meets all of the requirements of ASTM standard D3578-95

- 5.0 Device Description: Latex Patient Examination glove Powderfree (blue color) Polymer coated
- 6.0 Intended use: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
- 7.0 Surface treatment: Polymer coated, Halogenation/Siliconization and extensive washing in water Outer surface: Free from glove powder

as document and its contents are confidential. Do not discuss with or give access to people not designated.

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## 510(k) SUMMARY 01.11.1997

### ~ 9 QUALITY CHARACTERISTICS

| DESCRIPTION | ASTM standard | SPECIFICATION |
|-------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------|
| DIMENSION | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Overall length | 230 min. | 240+/-10 mm |
| Width<br>(double wall) | S 80 +/- 10 mm<br>M 95 +/- 10 mm<br>L 111 +/- 10 mm | SS ≤ 80 mm<br>S 83 +/- 5 mm<br>M 94 +/- 5 mm<br>L 105 +/- 4 mm<br>XL 110 +/- 5 mm |
| Thickness, mm | | |
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| palm | 0.08 mm MIN. | 0.08 mm MIN. |
| PHYSICAL PROPERTIES | S -2 AQL 4.0 | S-2 AQL 4.0 |
| Before and aging<br>Tensile strength<br>Elongation at break | According to<br>ASTM D3578-95 | 14 Mpa MIN<br>700% MIN. |
| After aging<br>Tensile strength<br>Elongation at break | | 14 Mpa MIN.<br>500% MIN. |
| WATER EXTRACTABLE<br>PROTEIN | N/A | S-2 AQL 4.0 |
| POWDER LEVEL | N/A | 2 mg MAX. |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |

9.0 Conclusion: Siam Sempermed Latex Patient Examination Glove Powderfree (blue color) polymer coated meet the ASTM standard or equivalent standard meet pinhole FDA requirements

meet labeling claims (see 5.0 and 6.0 above)

Pousank

Dr. POONSUK CHERDKIATGUMCHAI Corporate Officer (quality)

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all black, and they are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Nov 20 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIAM SEMPERMED CORPORATION, Limited C/O Mr. Don Morris SATARI Corporation, Limited 30798 US Hiqhway 19N Palm Harbor, Florida 34684

K981975 Re : Latex Patient Examination Glove Powder-Free Trade Name: (Blue Color) Polymer Coated Requlatory Class: I Product Code: LYY October 20, 1998 Dated: October 21, 1998 Received:

Dear Mr. Morris:

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, Drug, 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. A 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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Morris

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 diaqnostic 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth A. Ulat 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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510 (k) NUMBER (IF KNOWN) : __ K981975

DEVICE NAME: LATEX PATIENT EXAMINATION GLOVE -POWDER FREE POLYMER COATED - BLUE INDICATIONS FOR USE:

A MEDICAL GLOVE IS WORN ON THE HAND OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter-Use X
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K98 1975