Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE

K-Number: K891212 · 1989-04-14

ApplicantPro-Safe Professional Linens, Inc.
Decision Date1989-04-14
Product CodeFXO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Safe Professional Linens, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K891212. The device is classified under product code FXO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE?

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Pro-Safe Professional Linens, Inc.. The 510(k) number is K891212.

When did APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE receive FDA 510(k) clearance?

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE received FDA 510(k) clearance on 1989-04-14, under 510(k) number K891212.

Who is the listed applicant for APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE?

The FDA 510(k) record lists Pro-Safe Professional Linens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE?

The FDA product code for APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE is FXO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pro-Safe Professional Linens, 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.

K891210POCKETED WRAPS #3009 A,B,CK891216DENTAL EQUIPMENT PROTECTION DEVICESK891215FAST WRAP #M 101K891211SURGICAL GOWN #2001K891213SURGICAL INSTRUMENT POUCH #M102K891214DENTAL SURGICAL WRAP #3007 A,B,C

View all 7 devices →

Related Devices (Code: FXO)

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.

K914615BTP(TM) CENTRALINE(TM) SUITBtp Industries, Inc.K882282SUIT, SURGICALA Plus International, Inc.K865022SURGICAL GARMENTSUlti-Med Intl., Inc.K831207SPUNGUARD SCRUB SUITKimberly-Clark Corp.K822483MULTIPLE SCRUB SUITSurgilite Intl., 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.

↑