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FDA 510(k)

Latex Examination Gloves, Powder Free

K-Number: K213509 · 2022-04-08

ApplicantShandong Intco Medical Products Co, Ltd.
Decision Date2022-04-08
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Latex Examination Gloves, Powder Free is a medical device manufactured by Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2022-04-08 under approval number K213509. 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 Latex Examination Gloves, Powder Free?

Latex Examination Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K213509.

When was Latex Examination Gloves, Powder Free approved by the FDA?

Latex Examination Gloves, Powder Free received FDA 510(k) clearance on 2022-04-08, under approval number K213509.

What company makes Latex Examination Gloves, Powder Free?

Latex Examination Gloves, Powder Free is manufactured by Shandong Intco Medical Products Co, Ltd..

What is the FDA product code for Latex Examination Gloves, Powder Free?

The FDA product code for Latex Examination Gloves, Powder Free is LYY.

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Other Devices by Shandong Intco Medical Products Co, Ltd.

K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K231408Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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