Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007471500

FEI Number

3007471500

Entity Name

PT. UNIVERSAL GLOVES

City/State/Country

MEDAN Sumatera Utara, ID

Establishment Address

JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG, MEDAN Sumatera Utara 20361, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT. UNIVERSAL GLOVES (Owner Number: 10061303)

Owner / Operator Contact Address

JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG, MEDAN, ID-SU 20361, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201576

PMA Number

N/A

All Registered Proprietary Names

UNIVERSAL GLOVES UNIVERSAL GLOVES UNIVERSAL GLOVES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-21
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-21

Official Correspondent

SUTOPO SUTOPO

US Agent Details

SASITHARAN NAIR Email: snair@ammex.com Phone: (425) 2514000

Related Public Records

Same Entity

PT. UNIVERSAL GLOVES

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
K894452	Kerala Rubber & Reclaims, Ltd.	KRR GLOVE, PATIENT EXAMINATION GLOVES	1989-08-09
K891323	Li Wah-Hong Kong, Inc.	LI WAH LATEX EXAMINATION GLOVES	1989-08-31
K891418	C & K Mfg. & Sales Co.	LATEX EXAMINATION GLOVES, STYLE 510 LX	1989-06-22
K994255	Pt. Maja Agung Latexindo	LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE	2000-02-07
K892946	Yeou-Fwu Rubber Industrial Co., Ltd.	STERILE PATIENT EXAMINATION GLOVES	1989-08-10

Similar Registrations

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3017940518	STAR INVESTMENT AND TRADE JOINT STOCK COMPANY	Bac Ninh, VN
1000266564	SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED.	Hat Yai Songkhla, TH
8040653	ARISTA LATINDO INDUSTRIAL, LTD. P.T.	JAKARTA BARAT, ID
3002661124	ULINE, INC.	Pleasant Prairie, WI, US
3019769825	HARTALEGA NGC SDN. BHD. (LOT 39496)	Sepang Selangor, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007471500. Last updated year: 2026. Please use registration number 3007471500 when referencing this establishment in official correspondence.