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FDA 510(k)

LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)

K-Number: K891728 · 1989-05-25

ApplicantBaldur Systems Corp.
Decision Date1989-05-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) is the device name listed in this FDA 510(k) record. The listed applicant is Baldur Systems Corp.. It received FDA 510(k) clearance on 1989-05-25 under 510(k) number K891728. 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 EXAM GLOVES (MFG. KOON SENG SDN BHD)?

LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) is a medical device that received FDA 510(k) clearance on 1989-05-25. The listed applicant is Baldur Systems Corp.. The 510(k) number is K891728.

When did LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) receive FDA 510(k) clearance?

LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) received FDA 510(k) clearance on 1989-05-25, under 510(k) number K891728.

Who is the listed applicant for LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)?

The FDA 510(k) record lists Baldur Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)?

The FDA product code for LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD) 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 Baldur Systems Corp. 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.

K981823OPERATING ROOM TOWELSK974347BALDUR NON-STERILE COTTON SPONGESK892684PATIENT EXAMINATION GLOVES (LATEX)K891727LATEX EXAM GLOVES (MFG. RINDUMAS SDN BHD)K891726VINYL EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)

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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