LATEX PATIENT EXAMINATION GLOVE

K960942 · Siam Sempermed Corp., Ltd. · LYY · Sep 17, 1996 · General Hospital

Device Facts

• Record ID: K960942
• Device Name: LATEX PATIENT EXAMINATION GLOVE
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

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

Device Story

Latex patient examination glove; hypoallergenic; powder-free (talc-free); low protein content (≤50 micrograms/g). Worn by healthcare personnel to provide barrier protection against contamination from patient body fluids, waste, or environment. Manufactured to meet ASTM D3578-95 standards for physical properties and dimensions. Device serves as a protective barrier in clinical settings.

Clinical Evidence

Bench testing performed per ASTM D3578-95. Biocompatibility testing included Human Repeat Insult Patch Test (Study SAT-001 A N/E) showing no reactions, and Primary Dermal Irritation/Guinea Pig Sensitization (Ref T95-0189-1) per 16 CFR 1500.41, confirming non-irritant status.

Technological Characteristics

Latex patient examination glove; hypoallergenic; talc-free. Meets ASTM D3578-95. Protein content ≤50 µg/g. Physical properties: 14 MPa min tensile strength (before/after aging), 700% min elongation (before aging), 500% min elongation (after aging). Thickness ≥0.08 mm. Dimensions vary by size (S, M, L).

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)

{0}

Siam Sempermed Corporation.,Ltd
SEP 17 1996
K# 960942
Page 1 of 2

# 510(k) SUMMARY

07.02.1996

## 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 (Hypoallergenic)-801.YY meets all of the requirements of ASTM standard D3578-95

## 5.0 Device Description:

Latex Patient Examination glove (Hypoallergenic)
50 micrograms or less of total water extractable protein per gram of glove

## 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 Outer surface:

Free from talc (Magnesium silicate)

## 8.0 Human Repeat Insult Patch Test:

Concordia Research Laboratories, Inc. Study Number: SAT-001 A N/E
“From the complete lack of reactions noted during the Elicitation Phases (Challenge) of this test, it is evident that the irritation and allergenic potential of the test article is extremely low, If existent at all
It is the opinion of the undersigned that this product can be safely distributed for its intended use”

**Primary Dermal Irritation in Rabbits Guinea Pig Sensitization (Buehler):** Consumer Product Testing Co.
Experiment reference number T95-0189-1.
“According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.41), and under the conditions of this test, this test article is not a primary dermal irritant”.

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

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Siam Sempermed Corporation.,Ltd
510(k) SUMMARY
07.02.1996
Page 2 of 2

# 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
palm | 0.08 mm MIN. | 0.08 mm MIN. |
| 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 | 14 Mpa MIN. | 14 Mpa MIN. |
| After aging | 14 Mpa MIN. | 14 Mpa MIN. |
| Tensile strength | 500 % MIN. | 500% MIN. |
| Elongation at break | | |
| WATER EXTRACTABLE
PROTEIN | N/A | S-2 AQL 4.0
50 ug/g MAX. |
| POWDER LEVEL | N/A | 2.5 +/- 1.0 by weight |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |

10. Conclusion: Siam Sempermed Latex Patient Examination Glove (Hypoallergenic) meet or exceed the ASTM standard or equivalent standard meet pinhole FDA requirements meet labeling claims (see 5.0 and 6.0 above)

P. Cherdkiatgumchai

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.