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FDA 510(k)

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES

K-Number: K001094 · 2000-04-28

ApplicantJb Star Sdn Bhd
Decision Date2000-04-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Jb Star Sdn Bhd. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K001094. 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 SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES?

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Jb Star Sdn Bhd. The 510(k) number is K001094.

When did SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 2000-04-28, under 510(k) number K001094.

Who is the listed applicant for SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists Jb Star Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES?

The FDA product code for SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES is LYY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Jb Star Sdn Bhd 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.

K010546POWDER FREE LATEX EXAMINATION GLOVES

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.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder 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.

Official Source

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

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