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) → LYY — Latex Patient Examination Glove # LYY · Latex 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/LYY ## Overview - **Product Code:** LYY - **Device Name:** Latex 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 1954) Showing 20 most recent of 1954 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250069](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K250069.md) | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | Apr 29, 2025 | SESE | | [K240266](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K240266.md) | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | Sep 9, 2024 | SESE | | [K230573](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K230573.md) | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | Jun 13, 2023 | SESE | | [K223298](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K223298.md) | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | Feb 22, 2023 | SESE | | [K222612](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K222612.md) | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Nov 25, 2022 | SESE | | [K221667](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K221667.md) | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | Oct 28, 2022 | SESE | | [K222348](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K222348.md) | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Oct 27, 2022 | SESE | | [K221374](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K221374.md) | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | Oct 26, 2022 | SESE | | [K222693](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K222693.md) | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | Sep 24, 2022 | SESE | | [K221648](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K221648.md) | Iconic Latex Glove | Iconic Medicare Sdn Bhd | Aug 25, 2022 | SESE | | [K211601](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K211601.md) | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | Aug 22, 2022 | SESE | | [K212482](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212482.md) | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | Aug 9, 2022 | SESE | | [K214017](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K214017.md) | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | Jul 14, 2022 | SESE | | [K221185](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K221185.md) | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | Jun 22, 2022 | SESE | | [K212597](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212597.md) | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | May 28, 2022 | SESE | | [K213775](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K213775.md) | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | Apr 24, 2022 | SESE | | [K213509](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K213509.md) | Latex Examination Gloves, Powder Free | Shandong Intco Medical Products Co, Ltd. | Apr 8, 2022 | SESE | | [K212309](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212309.md) | Non-sterile, Powder-Free Latex Examination Glove | Sri Trang Gloves (Thailand) Public Company Limited | Apr 8, 2022 | SESE | | [K213073](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K213073.md) | Goody Gloves, Wincare, TBG Gloves | Thai Rubber Gloves Co., Ltd. | Dec 29, 2021 | SESE | | [K212438](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212438.md) | Comfortpro | Thai Rubber Industry Company Limited | Dec 7, 2021 | SESE | ## Top Applicants - Wembley Rubber Products (M) Sdn Bhd — 37 clearances - Sgmp Co., Ltd. — 25 clearances - Hartalega Sdn Bhd — 19 clearances - Siam Sempermed Corp., Ltd. — 19 clearances - Perusahaan Getah Asas Sdn. Bhd. — 16 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) **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