LATEX PATIENT EXAMINATION GLOVE (PINK)

K961602 · Siam Sempermed Corp., Ltd. · LYY · Oct 7, 1996 · General Hospital

Device Facts

• Record ID: K961602
• Device Name: LATEX PATIENT EXAMINATION GLOVE (PINK)
• 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 (pink color) designed as a protective barrier for healthcare personnel. Worn on hands to prevent cross-contamination between wearer and patient body, fluids, waste, or environment. Device is a pre-powdered latex glove. Used in clinical or healthcare settings. Provides physical barrier protection.

Clinical Evidence

Bench testing only. Guinea pig sensitization (Buehler) study (Ref: T95-02) 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; pink color. Dimensions: 240+/-10 mm length; 0.08 mm minimum thickness. Physical properties: 14 MPa minimum tensile strength; 700% minimum elongation before aging. Meets ASTM D3578-95 standards.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier 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
510(k) SUMMARY 01.04.1996
K961602
Page 1 of 2

# 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 (PINK color)-80LYY meets all of the requirements of ASTM standard D3578-95

# 5.0 Device Description:

Latex Patient Examination glove (PINK 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.
H

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Siam Sempermed
Corporation.,Ltd
①
K961602
Page 2 of 2

# 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 |

PINK

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.