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FDA 510(k)

P2 NITRILE EXAM GLOVES

K-Number: K944095 · 1994-10-28

ApplicantBiosafety Systems, Inc.
Decision Date1994-10-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

P2 NITRILE EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Biosafety Systems, Inc.. It received FDA 510(k) clearance on 1994-10-28 under 510(k) number K944095. 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 P2 NITRILE EXAM GLOVES?

P2 NITRILE EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1994-10-28. The listed applicant is Biosafety Systems, Inc.. The 510(k) number is K944095.

When did P2 NITRILE EXAM GLOVES receive FDA 510(k) clearance?

P2 NITRILE EXAM GLOVES received FDA 510(k) clearance on 1994-10-28, under 510(k) number K944095.

Who is the listed applicant for P2 NITRILE EXAM GLOVES?

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

What is the FDA product code for P2 NITRILE EXAM GLOVES?

The FDA product code for P2 NITRILE EXAM GLOVES is LYY.

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Other records listing Biosafety Systems, 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.

K952274CHEMOGUARD, P2 HIRISKK944514P2 NITRILE EXAM GLOVESK944142P2 EXAM GLOVESK921313AEROSTARK904130CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)K901411CHEMOPLUS GLOVE

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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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