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FDA 510(k)

ANSELL DENTA GLOVES

K-Number: K895660 · 1990-01-02

ApplicantAnsell, Inc.
Decision Date1990-01-02
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANSELL DENTA GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Ansell, Inc.. It received FDA 510(k) clearance on 1990-01-02 under 510(k) number K895660. 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 ANSELL DENTA GLOVES?

ANSELL DENTA GLOVES is a medical device that received FDA 510(k) clearance on 1990-01-02. The listed applicant is Ansell, Inc.. The 510(k) number is K895660.

When did ANSELL DENTA GLOVES receive FDA 510(k) clearance?

ANSELL DENTA GLOVES received FDA 510(k) clearance on 1990-01-02, under 510(k) number K895660.

Who is the listed applicant for ANSELL DENTA GLOVES?

The FDA 510(k) record lists Ansell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANSELL DENTA GLOVES?

The FDA product code for ANSELL DENTA GLOVES is LYY.

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Other records listing Ansell, Inc. 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.

K984392ANSELL CONDOMSK983518LIFESTYLES XTRA PLEASUREK940047SPERMICIDALLY LUBRICATED CONDOMK953379HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVEK945766HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVESK945767POWDER FREE, HYPOALLERGENIC AMBIDEXTROUS PATIENT EXAMINATION GLOVES

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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.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

View on FDA Database →

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

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