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FDA 510(k)

MAYTEX NON-STERILE LATEX EXAM GLOVE

K-Number: K892557 · 1989-05-31

ApplicantAmerican Seal Co.
Decision Date1989-05-31
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAYTEX NON-STERILE LATEX EXAM GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is American Seal Co.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K892557. 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 MAYTEX NON-STERILE LATEX EXAM GLOVE?

MAYTEX NON-STERILE LATEX EXAM GLOVE is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is American Seal Co.. The 510(k) number is K892557.

When did MAYTEX NON-STERILE LATEX EXAM GLOVE receive FDA 510(k) clearance?

MAYTEX NON-STERILE LATEX EXAM GLOVE received FDA 510(k) clearance on 1989-05-31, under 510(k) number K892557.

Who is the listed applicant for MAYTEX NON-STERILE LATEX EXAM GLOVE?

The FDA 510(k) record lists American Seal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAYTEX NON-STERILE LATEX EXAM GLOVE?

The FDA product code for MAYTEX NON-STERILE LATEX EXAM GLOVE 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 American Seal Co. 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.

K972187BOUFFANT CAPK972227SHOE COVERK970814NON-STERILE ISOLATION GOWNK964358AMSEAL SURGICAL FACE MASKK892553MAYTEX PATIENT 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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