← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K961415 # LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION) (K961415) _Siam Sempermed Corp., Ltd. · LYY · Oct 7, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K961415 ## 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:** Oct 7, 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 (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. ## 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 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: 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 ( 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. {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K961415](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K961415) **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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