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FDA 510(k)

GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION

K-Number: K981488 · 1998-07-07

ApplicantOak Carolina, Inc.
Decision Date1998-07-07
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Oak Carolina, Inc.. It received FDA 510(k) clearance on 1998-07-07 under 510(k) number K981488. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION?

GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Oak Carolina, Inc.. The 510(k) number is K981488.

When did GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION receive FDA 510(k) clearance?

GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981488.

Who is the listed applicant for GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION?

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

What is the FDA product code for GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION?

The FDA product code for GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION is LYZ.

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Other records listing Oak Carolina, 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.

K981963SENSITEX EXAMINATION GLOVEK952050GLOVE, EXAMINATION, VINYL

Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

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