LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)

K961415 · Siam Sempermed Corp., Ltd. · LYY · Oct 7, 1996 · General Hospital

Device Facts

• Record ID: K961415
• Device Name: LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste, or environment

Device Story

Latex patient examination glove (BIVE color); worn on hands by healthcare personnel. Acts as physical barrier to prevent contamination between wearer and patient body, fluids, waste, or environment. Pre-powdered inner surface. Device used in clinical or healthcare settings to protect both patient and provider.

Clinical Evidence

Bench testing only. Guinea pig sensitization (Buehler) study (Ref: T95-02) conducted at Prince of Songkla University showed no evidence of sensitization in test or control groups, suggesting minimal risk of contact sensitization in humans.

Technological Characteristics

Latex patient examination glove; pre-powdered. Meets ASTM D3578-95. Physical properties: 14 MPa min tensile strength (before/after aging), 700% min elongation (before aging), 500% min elongation (after aging). Thickness 0.08 mm min. Freedom from holes AQL 1.5.

Indications for Use

Indicated for use by healthcare and similar personnel to prevent cross-contamination between the wearer and the patient's body, fluids, waste, or environment.

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 Corporation.,Ltd
OCT -7 1996
Page 1 of 2

# 510(k) SUMMARY
01.04.1996

K961415

## 1.0 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
14 LEEWARD ISLAND
CLEARWATER
USA FL 34630
TEL: [phone] OR 800 366 9545
FAX: [phone]

## 3.0 Device Class: I
Product code: 80LYY

## 4.0 Specification:
Class I Latex patient examination glove ( BIVE color)-80LYY meets all of the requirements of ASTM standard D3578-95

## 5.0 Device Description:
Latex Patient Examination glove ( BIVE color)

## 6.0 Intended use:
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste, or environment

## 7.0 Inner surface:
Pre-powder

## 8.0 Guinea pig Sensitization (Buehler):
Prince of Songkla University, Department of Pharmacology
Faculty of Science: Experiment Reference number T95-02
Guinea pig sensitization (Buehler) “There was no evidence of sensitization in both induced (test) guinea pigs and control groups. The results suggest that the risk of contact sensitization in human should be minimal”

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

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K961415

Siam Sempermed Corporation.,Ltd

510(k) SUMMARY 01.04.1996

# 9.0 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
(double wall) | S 80 +/- 10 mm
M 95 +/- 10 mm
L 111 +/- 10 mm | SS 77 +/- 5 mm
S 83 +/- 5 mm
M 94 +/- 5 mm
L 105 +/- 4 mm |
| Thickness, mm | 0.08 mm MIN. | 0.08 mm MIN. |
| Finger | 0.08 mm MIN. | 0.08 mm MIN. |
| palm | | |
| PHYSICAL PROPERTIES | S-2 AQL 4.0 | S-2 AQL 4.0 |
| Before aging | 14 Mpa MIN. | 14 Mpa MIN |
| Tensile strength | 700 % MIN. | 700% MIN. |
| Elongation at break | | |
| After aging | 14 Mpa MIN. | 14 Mpa MIN. |
| Tensile strength | 500% MIN. | 500% MIN. |
| Elongation at break | | |
| POWDER LEVEL | N/A | S-2 AQL 4.0 |
| Inside | | 2.5+/-1.0% |
| Outside | | 1.0% MAX. |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |

# BIVE

10. Conclusion: Siam Sempermed Latex Patient Examination Glove ( color)

meet ASTM standard

meet pinhole FDA requirements

meet labeling claims (see 5.0 and 6.0 above)

P. Cherdkatzumchai

Dr. POONSUK CHERDKIATGUMCHAI

Senior Assistant Chief Production Officer (quality)

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