← Product Code [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ) · K964321 # GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) (K964321) _Shijiazhuang Hongray Plastic Products Co., Ltd. · LYZ · Jan 9, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K964321 ## Device Facts - **Applicant:** Shijiazhuang Hongray Plastic Products Co., Ltd. - **Product Code:** [LYZ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ.md) - **Decision Date:** Jan 9, 1997 - **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 Vinyl patient examination glove; ambidextrous; prepowdered. Worn by healthcare personnel to provide a protective barrier against contamination. Device acts as a physical barrier between the wearer and patient fluids/waste. No electronic, software, or algorithmic components. ## Clinical Evidence No clinical data. Biocompatibility testing performed including primary dermal irritation in rabbits and Guinea Pig sensitization (Buehler). Bench testing conducted per ASTM D5250 and FDA water leak test (pinhole rate <4%). ## Technological Characteristics Vinyl material; prepowdered; ambidextrous; 10-inch length. Thickness: 0.08mm (finger), 0.09mm (cuff), 0.15mm (palm). Tensile strength min 10.0 MPa; elongation min 350%. Meets ASTM D5250 and JIS-S-2045 standards. ## 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} K964321 H-RAY JAN - 9 1997 # ShiJiaZhuang HongRay Plastic Products Co., Ltd. HEAD OFFICE NO. 135 XIN HUA WEST ROAD, SHIJIAZHUANG CITY, & FACTORY HEBEI PROVINCE, CHINA P.O. BOX, 050081 TEL. 86 311-334449 334221 BRANCH OFFICE, RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION I, TAIPEI, TAIWAN P.O. BOX, 53-186, TAIPEI TEL. 886-2-7720306-7 7110338 7217339 FAX. 886-2-7712601 TELEX. 22602 KENAN OUR REF. 510(K) SUMMARY - K964321 1.0 APPLICANT: MR. LIN CHIN YU SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST RD. SHIJIAZHUANG, CHINA TEL. 886 2 772-0306-7 FAX. 886 2 771-2601 2.0 CONTACT PERSON MR. LIN CHIN YU SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS NO. 135 XIN-HUA WEST RD. SHIJIAZHUANG, CHINA TEL. 886 2 772-0306-7 FAX. 886 2 771-2601 AGENT: MR. DON MORRIS 14 LEEWARD ISLAND CLEARWATER, FL. 34630 USA TEL. 800-366-9545 FAX. 813-443-3482 3.0 Device Class: 1 Product Code: 80LYZ 4.0 Specification: Glove, Patient Examination, Vinyl (Powdered) meets all of the requirements of ASTM Standard D5250 5.0 Device Description: Glove, Patient Examination, Vinyl (Powdered) 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: Prepowdered 8.0 Biocompatibility Testing: Primary Dermal Irritation in Rabbits and Guinea Pig Sensitization (Buehler) by Consumer Products Testing Co., USA. {1} H-RAY Shijiazhuang HongRay Plastic Products Co., Ltd. HEAD OFFICE NO. 135 XIN HUA WEST ROAD, SHIJIAZHUANG CITY, K. FACTORY ' HEBEI PROVINCE, CHINA P.O. BOX, 050081 TEL. 86 311-334449 334221 BRANCH OFFICE, RM3, 5TH FL., NO. 76 FUSHING SOUTH ROAD, SECTION I, TAIPEI, TAIWAN P.O. BOX, 53-186, TAIPEI TEL. 886-2-7720306-7 7110338 7217339 FAX. 886-2-7712601 TEL.EX, 22602 KENAN YOUR REF. 510(K) SUMMARY Page 2 of 2 ## 9.0 Quality Characteristics SPECIFICATION OF VINYL GLOVES (ANBIDEXTROUS) POWDER 10" | SIZE SPEC | SMALL | MEDIUM | LARGE | X-LARGE | TEST CODE | | --- | --- | --- | --- | --- | --- | | CIRCUMFERENCE OF PALM (M/M) (INCH) | 178 6-3/4 | 210 7-3/4 | 218 8-1/2 | 230 9 | JIS-S-2045.5.9 | | TOTAL LENGTH (±5M/M) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 | | LNGTH OF FINGERS (M/M) THUMBS | 55 | 57 | 61 | 63 | JIS-2045.5.9 | | INDEX FINGER | 66 | 70 | 75 | 78 | | | MIDDLE FINGER | 74 | 81 | 88 | 92 | | | RING FINGER | 69 | 74 | 79 | 82 | | | LITTLE FINGER | 54 | 55 | 60 | 62 | | | CIRCUMFERENCE FINGERS THUMB | 63 | 71 | 78 | 83 | JIS-S-2045.5.9 | | INDEX FINGER | 56 | 64 | 70 | 74 | | | MIDDLE FINGER | 59 | 66 | 72 | 76 | | | RING FINGER | 56 | 63 | 69 | 73 | | | LITTLE FINGER | 50 | 57 | 62 | 66 | | | TENSILE STRENGTH (Mpa) | Min. 10.0 | Min. 10.00 | Min. 10.00 | Min. 10.00 | JIS-2045.5.2 | | ELONGATION (Min.) | 350% | 350% | 350% | 350% | JIS-2045.5.2 | | WEIGHT (g/pc) | 7.0 | 8.0 | 9.0 | 9.5 | ±0.2g | | THICKNESS | Finger Tip 0.08mm ± 0.02mm Cuff 0.09mm ± 0.02mm Palm 0.15mm ± 0.02mm | | | | | | QUALITY ASSURANCE | UNDER 4% PINHOLE RATE | | | | FDA GLOVE 1000 ML WATER LEAK TEST | 10.0 Conclusion: Shinjiazhuang Hongray Plastic Products Co., Ltd. Vinyl Patient Examination Gloves meet ASTM Standards - meets pinhole requirements and labeling claims. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K964321](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYZ/K964321) **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