Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004133257

FEI Number

3004133257

Entity Name

AMMAR APPAREL II S. DE R.L DE C.V.

City/State/Country

CALKINI Campeche, MX

Establishment Address

Av. Bernstein S/N Entre Calle 20 y, Carretera Federal Campeche - Merida, CALKINI Campeche 24905, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AMMAR APPAREL II S. DE R.L DE C.V. (Owner Number: 9057879)

Owner / Operator Contact Address

Av. Bernstein S/N Entre Calle 20 y, Carretera Federal Campeche - Merida, Tepakan, Calkini, MX-CAM 24905, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline non-sterile surgical gown Medline surgical gowns / drapes Medline sterilization wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-09-25
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-08-30
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-10-29
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-10-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-10-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-04-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-10-22
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2014-12-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-12-16
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-10-29
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-12-15
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2026-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

AMMAR APPAREL II S. DE R.L DE C.V.

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
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Similar Registrations

Registration Number	Establishment Name	Location
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3019798849	EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD.	U-Thai District Phra Nakhon Si Ayutthaya, TH
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004133257. Last updated year: 2026. Please use registration number 3004133257 when referencing this establishment in official correspondence.