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

FDA 510(k)

Medline Orbis LVL 3 Surgical Gown

K-Number: K220333 · 2022-05-18

ApplicantMedline Industries, LP
Decision Date2022-05-18
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Orbis LVL 3 Surgical Gown is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-05-18 under approval number K220333. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Orbis LVL 3 Surgical Gown?

Medline Orbis LVL 3 Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by Medline Industries, LP. The 510(k) number is K220333.

When was Medline Orbis LVL 3 Surgical Gown approved by the FDA?

Medline Orbis LVL 3 Surgical Gown received FDA 510(k) clearance on 2022-05-18, under approval number K220333.

What company makes Medline Orbis LVL 3 Surgical Gown?

Medline Orbis LVL 3 Surgical Gown is manufactured by Medline Industries, LP.

What is the FDA product code for Medline Orbis LVL 3 Surgical Gown?

The FDA product code for Medline Orbis LVL 3 Surgical Gown is FYA.

Other Devices by Medline Industries, LP

K220365Gemini Sterilization Wrap K221360Medline UNITE® Medial Malleolus Peg Plate System K214108Medline Orbis Chemo Surgical Gown K220511Medline UNITE IM Fibula Implant K213567Medline UNITE Calcaneal Fracture Plating System K231211Medline ComfortTemp Patient Warming System

View all 29 devices →

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, 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.

↑