Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003495693

FEI Number

3003495693

Entity Name

EMERALD NONWOVENS INTL. CO., LTD.

City/State/Country

Phetchaburi, TH

Establishment Address

88, 88/1 MOO 2, NONG CHUMPON NEAN, KAO-YOI, Phetchaburi 76140, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EMERALD NONWOVENS INTL. CO., LTD. (Owner Number: 9047422)

Owner / Operator Contact Address

23/302-303 MOO 8 SOI, PHONGSIRICHAI #1 PHETKASAM RD, OPMYAI,SAMPRAN,NAKORN,PRATHON, TH-NOTA 73160, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gemini Sterilization Wrap BOUFFANT CAP BEDPADS UNDERPADS SHEETS Face Mask Chemo Surgical Gown DISPOSABLE PATIENT ISOLATION GOWN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2012-01-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-09-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-12-19
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2013-02-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-06-26
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2016-01-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-09-01
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2001-08-24
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2014-02-27
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-02-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-06-20
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-29
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-05-31
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2006-09-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-02-19
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2008-02-19
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-09-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-04-21
OUK	Surgical Mask With Antimicrobial/Antiviral Agent	General, Plastic Surgery	Class 2	878.4040	2013-05-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-12-26
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-04-05
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2018-04-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-10
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-29
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2021-04-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2017-02-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-06-26
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-21
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-17
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2006-02-03
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2018-04-05
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2001-08-24
FME	Gown, Examination	General Hospital	Class 1	880.6265	2003-11-24
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Sam Kao Email: samkao@icloud.com Phone: (714) 9535326

Related Public Records

Same Entity

EMERALD NONWOVENS INTL. CO., LTD.

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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

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3020468145	SHANGHAI LEJOY CO., LTD	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003495693. Last updated year: 2026. Please use registration number 3003495693 when referencing this establishment in official correspondence.