UNISAFE INC.

FDA Device Registration & Listing · BOHEMIA, NY, US · Registration 3005322833

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005322833
FEI Number
3005322833
Entity Name
UNISAFE INC.
City/State/Country
BOHEMIA, NY, US
Establishment Address
80 Orville Dr, Ste 112, BOHEMIA, NY 11716, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
UNISAFE INC. (Owner Number: 9102881)
Owner / Operator Contact Address
PO Box 395, --, Bohemia, NY 11716, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K132484
PMA Number
N/A

All Registered Proprietary Names

ON GUARD Topgrip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-04-04
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-05-23
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2025-04-29

Official Correspondent

LAWRENCE DRUCKER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UNISAFE INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

Similar Registrations

Registration Number Establishment Name Location
3030671502 GUANGDONG VYIMED CO., LTD. Qingyuan Guangdong, CN
9610406 ANSELL (THAILAND) LTD. THAILAND Krung Thep Maha Nakhon, TH
3026062711 RMKH GLOVE (CAMBODIA) CO., LTD. Bavet City Svay Rieng, KH
3043739177 US Paper Mill LLC Chillicothe, OH, US
3042765418 VITAL EDGE INSTRUMENTS LLC Leesburg, VA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005322833. Last updated year: 2026. Please use registration number 3005322833 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.