← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K970794 # LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) (K970794) _Siam Sempermed Corp., Ltd. · LYY · May 6, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K970794 ## 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:** May 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for 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. ## 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} Page 1 of 2 ```markdown # 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: 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: 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.” {1} Page 2 of 2 ```markdown # 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
meet the ASTM standard or equivalent standard
meet pinhole FDA requirements
meet labeling claims (see 5.0 and 6.0 above) 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/K970794](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K970794) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com