Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) → FMC — Patient Examination Glove # FMC · Patient Examination Glove _General Hospital · 21 CFR 880.6250 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC ## Overview - **Product Code:** FMC - **Device Name:** Patient Examination Glove - **Regulation:** [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K042618](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K042618.md) | LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) | La Glove (M) Sdn. Bhd. | Nov 26, 2004 | SESE | | [K014134](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K014134.md) | POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G) | Supergrade Healthcare Products Sdn. Bhd. | Jan 22, 2002 | SESE | | [K992337](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K992337.md) | BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA | Mexpo Intl., Inc. | Aug 17, 1999 | SESE | | [K932405](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K932405.md) | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | Safeskin Corp. | May 18, 1994 | SESE | | [K932404](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K932404.md) | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | Safeskin Corp. | May 18, 1994 | SESE | | [K923175](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K923175.md) | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | Jun 17, 1993 | SESE | | [K920649](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K920649.md) | COMPASEP | Wilde-USA, Inc. | Jul 23, 1992 | SESE | | [K915376](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K915376.md) | GLASION VARNISH | Sci-Pharm Scientific Pharmaceutical, Inc. | Jan 22, 1992 | SESE | | [K905127](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K905127.md) | LATEX GLOVE APPLICATION AND REMOVAL SYSTEM | Success Builders Intl., Inc. | Jan 30, 1991 | SESE | | [K905109](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K905109.md) | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | Tactyl Technologies, Inc. | Nov 21, 1990 | SESE | | [K903746](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K903746.md) | COMFIT, PATIENT EXAMINATION GLOVES | Wembley Rubber Products (M) Sdn Bhd | Sep 5, 1990 | SESE | | [K902278](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K902278.md) | PVC PATIENT EXAMINATION GLOVE | Fujian Province Jiu Zhou Group | Aug 29, 1990 | SESE | | [K883805](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K883805.md) | ROCKET SEX CRIME KIT | A & A Medical, Inc. | Jan 31, 1989 | SESE | | [K885346](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K885346.md) | NON-STERILE VINYL GLOVES | Daw Shin Industrial Co., Ltd. | Jan 18, 1989 | SESE | | [K882533](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K882533.md) | LATEX EXAMINATION GLOVE | Sukas Export | Jul 21, 1988 | SESE | | [K882583](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K882583.md) | LATEX EXAM GLOVES, NON-STERILE | B Und J Instruments | Jul 14, 1988 | SESE | | [K840620](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K840620.md) | TPN/CVP DRESSING CHANGE KIT | Marwood Medical, Inc. | May 30, 1984 | SESE | | [K833758](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K833758.md) | P.T.I. DRESSING CHANGE TRAYS | Packaging Technologies, Inc. | Jan 26, 1984 | SESE | | [K831964](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K831964.md) | CMS 2000 SERIES TPN KITS | Currie Medical Specialties, Inc. | Aug 11, 1983 | SESE | | [K831564](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC/K831564.md) | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | Jul 12, 1983 | SESE | ## Top Applicants - Jamar Health Products — 2 clearances - Phoenix Glove Co. — 2 clearances - Pollak (Intl.), Ltd. — 2 clearances - Safeskin Corp. — 2 clearances - A & A Medical, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FMC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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