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FDA 510(k)

PATIENT PREP KITS/TRAYS-STERILE

K-Number: K821044 · 1982-06-23

ApplicantPhoenix Glove Co.
Decision Date1982-06-23
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT PREP KITS/TRAYS-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Glove Co.. It received FDA 510(k) clearance on 1982-06-23 under 510(k) number K821044. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT PREP KITS/TRAYS-STERILE?

PATIENT PREP KITS/TRAYS-STERILE is a medical device that received FDA 510(k) clearance on 1982-06-23. The listed applicant is Phoenix Glove Co.. The 510(k) number is K821044.

When did PATIENT PREP KITS/TRAYS-STERILE receive FDA 510(k) clearance?

PATIENT PREP KITS/TRAYS-STERILE received FDA 510(k) clearance on 1982-06-23, under 510(k) number K821044.

Who is the listed applicant for PATIENT PREP KITS/TRAYS-STERILE?

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

What is the FDA product code for PATIENT PREP KITS/TRAYS-STERILE?

The FDA product code for PATIENT PREP KITS/TRAYS-STERILE is FRG.

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 Phoenix Glove 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.

K830660STERILE SURGICAL DRAPESK821666STERILE SURGICAL DRAPESK821043STERILE PATIENT EXAM. GLOVESK801846ELECTROCARDIOGRAPH ELECTRODEK781820GLOVES, VINYL EXAMINATION

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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