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FDA 510(k)

LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES)

K-Number: K892319 · 1989-08-22

ApplicantSvenska Medita Ac.
Decision Date1989-08-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES) is the device name listed in this FDA 510(k) record. The listed applicant is Svenska Medita Ac.. It received FDA 510(k) clearance on 1989-08-22 under 510(k) number K892319. 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. KOSSAN LATEX INDUSTRIES)?

LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES) is a medical device that received FDA 510(k) clearance on 1989-08-22. The listed applicant is Svenska Medita Ac.. The 510(k) number is K892319.

When did LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES) receive FDA 510(k) clearance?

LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES) received FDA 510(k) clearance on 1989-08-22, under 510(k) number K892319.

Who is the listed applicant for LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES)?

The FDA 510(k) record lists Svenska Medita Ac. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES)?

The FDA product code for LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES) 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.

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Other records listing Svenska Medita Ac. 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.

K892318VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)K892317VINYL EXAM GLOVES (MFG. TSE FONG)

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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