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FDA 510(k)

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

K-Number: K223298 · 2023-02-22

ApplicantShandong Intco Medical Products Co, Ltd.
Decision Date2023-02-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is a medical device manufactured by Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-02-22 under approval number K223298. 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 Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K223298.

When was Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) approved by the FDA?

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) received FDA 510(k) clearance on 2023-02-22, under approval number K223298.

What company makes Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is manufactured by Shandong Intco Medical Products Co, Ltd..

What is the FDA product code for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)?

The FDA product code for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) is LYY.

Related Clinical Trials

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Other Devices by Shandong Intco Medical Products Co, Ltd.

K213509Latex Examination Gloves, Powder Free 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

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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