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FDA 510(k)

Single-use medical latex examination gloves (LG100)

K-Number: K222693 · 2022-09-24

ApplicantFitone Latex Products Co., Ltd. Guangdong
Decision Date2022-09-24
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Single-use medical latex examination gloves (LG100) is a medical device manufactured by Fitone Latex Products Co., Ltd. Guangdong. It received FDA 510(k) clearance on 2022-09-24 under approval number K222693. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-use medical latex examination gloves (LG100)?

Single-use medical latex examination gloves (LG100) is a medical device that received FDA 510(k) clearance on 2022-09-24. It is manufactured by Fitone Latex Products Co., Ltd. Guangdong. The 510(k) number is K222693.

When was Single-use medical latex examination gloves (LG100) approved by the FDA?

Single-use medical latex examination gloves (LG100) received FDA 510(k) clearance on 2022-09-24, under approval number K222693.

What company makes Single-use medical latex examination gloves (LG100)?

Single-use medical latex examination gloves (LG100) is manufactured by Fitone Latex Products Co., Ltd. Guangdong.

What is the FDA product code for Single-use medical latex examination gloves (LG100)?

The FDA product code for Single-use medical latex examination gloves (LG100) is LYY.

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025)

Other Devices by Fitone Latex Products Co., Ltd. Guangdong

K211927Nitrile examination gloves K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K231446Single-Use Latex Sterile Surgical Gloves (SG100)

Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd

Official Source

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