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FDA 510(k)

Latex Examination Glove Powder Free (Ocean Blue and Natural White)

K-Number: K240266 · 2024-09-09

ApplicantSri Trang Gloves (Thailand) Public Company Limited
Decision Date2024-09-09
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Latex Examination Glove Powder Free (Ocean Blue and Natural White) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K240266. 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 Glove Powder Free (Ocean Blue and Natural White)?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K240266.

When did Latex Examination Glove Powder Free (Ocean Blue and Natural White) receive FDA 510(k) clearance?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) received FDA 510(k) clearance on 2024-09-09, under 510(k) number K240266.

Who is the listed applicant for Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Public Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

The FDA product code for Latex Examination Glove Powder Free (Ocean Blue and Natural White) is LYY.

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Other records listing Sri Trang Gloves (Thailand) Public Company Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- BlueK232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and FentanylK212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural WhiteK212309Non-sterile, Powder-Free Latex Examination GloveK200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K230573Powder 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 BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

Official Source

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