← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K960942 # LATEX PATIENT EXAMINATION GLOVE (K960942) _Siam Sempermed Corp., Ltd. · LYY · Sep 17, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960942 ## Device Facts - **Applicant:** Siam Sempermed Corp., Ltd. - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Sep 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## 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; 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). ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 66 074 291 648 OR 291 649 FAX: 66 074 291 650 ## 2.0 CONTACT PERSON Dr. POONSUK CHERDKIATGUMCHAI SIAM SEMPERMED CORPORATION.,Ltd 110 MOO 8 KANJANAVANIT ROAD PATHONG HATYAI SONGKHLA THAILAND 90230 TEL: 66 074 291 648 OR 291 649 FAX: 66 074 291 650 MR DON MORRIS SATARI CORP.,Ltd 14 LEEWARD ISLAND CLEARWATER USA FL 34630 TEL: 813 446 3535 OR 800 366 9545 FAX: 813 443 348 ## 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. {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960942](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K960942) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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