Cleared Traditional

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (K221082) - FDA 510(k) Clearance

Class I General Hospital device.

K221082 · Rhino Health, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
231d
Days
Class 1
Risk

K221082 is an FDA 510(k) clearance for the Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Rhino Health, Inc. (Church Rock, US). The FDA issued a Cleared decision on November 30, 2022 after a review of 231 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Rhino Health, Inc. devices

Submission Details

510(k) Number K221082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2022
Decision Date November 30, 2022
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Global Regulatory Partners, Inc.
Suzan Davis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K221082.
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K222715 · Safeskin Retailing (Hk) Limited · Dec 2022
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K222720 · Safeskin Retailing (Hk) Limited · Dec 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
K221747 · Fitone Latex Products Co., Ltd. Guangdong · Dec 2022
Nitrile Patient Examination Glove
K222534 · Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd. · Nov 2022
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl
K221165 · Sri Trang Gloves (Thailand) Public Company Limited · Nov 2022
Nitrile Examination Gloves
K213981 · Emerald Glove Manufacturing Sdn Bhd · Nov 2022