LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)

K970794 · Siam Sempermed Corp., Ltd. · LYY · May 6, 1997 · General Hospital

Device Facts

• Record ID: K970794
• Device Name: LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
• Applicant: Siam Sempermed Corp., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: May 6, 1997
• 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

Latex patient examination glove; powder-free; polymer coated; processed via halogenation/siliconization and extensive water washing. Designed for use by healthcare professionals to provide a barrier against contamination. Reduces protein content to 50 micrograms or less per gram of glove. Tested for irritation and sensitization via Human Repeat Insult Patch Test.

Clinical Evidence

Human Repeat Insult Patch Test conducted by Concordia Research Laboratories, Inc. Results showed no reactions during Induction or Challenge Phases; concluded irritation and sensitization potential is extremely low.

Technological Characteristics

Material: Latex. Surface: Polymer coated, halogenated, siliconized. Protein content: ≤ 50 ug/g. Powder level: ≤ 2 mg. Dimensions: 240+/-10 mm length, 0.08 mm min thickness. Physical properties: 14 MPa min tensile strength, 700% min elongation (before aging). Standards: ASTM D3578-95.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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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# 510(k) SUMMARY

**MAY - 6 1997**
**510(k) SUMMARY**
**08.01.1997**
**FOR K-970794**

## 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:

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
50 micrograms or less of total water extractable protein per gram of glove

## 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

## 8.0 Human Repeat Insult Patch Test:

Concordia Research Laboratories, Inc. Study Number:
“Because of the complete lack of reactions during both the Induction and Challenge Phases, it is apparent that this test glove, when tested under the exaggerated conditions of the Occluded Repeated Insult Patch Test, may be safely distributed for its intended use.
It is the opinion of the investigator and dermatologist that the irritation and sensitization potential of the above captioned test article is extremely low, if existent at all.”

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# 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 ≤ 80 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 and aging | According to ASTM D3578-95 | 14 Mpa MIN
700% MIN. |
| Tensile strength | | |
| Elongation at break | | |
| Per aging | | 14 Mpa MIN.
500% MIN. |
| Tensile strength | | |
| Elongation at break | | |
| WATER EXTRACTABLE PROTEIN | N/A | S-2 AQL 4.0
50 ug/g MAX. |
| POWDER LEVEL | N/A | 2 mg MAX. |
| FREEDOM FROM HOLE | S-4 AQL 4.0 | II AQL 1.5 |

10. Conclusion: Siam Sempermed Latex Patient Examination Glove polymer Powderfree<br/>
meet the ASTM standard or equivalent standard<br/>
meet pinhole FDA requirements<br/>
meet labeling claims (see 5.0 and 6.0 above)

Dr. POONSUK CHERDKIATGUMCHAI<br/>
Senior Assistant Chief Production Officer (quality)

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