5 Nitrile Glove Factories in Thailand that are currently on the FDA Import Alert

CDRH has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the U. S. surgeon's and examination gloves are widely used by health care professionals and others as a barrier to blood-borne diseases and pathogens. Defective medical gloves present a potential hazard to health for users as well as patients. Therefore, continuous monitoring of these medical gloves is needed.

Guidance:

CDRH may detain without physical examination, all shipments from the manufacturers/shippers listed on this alert.

NOTE:
Because the presence of defects in medical gloves represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations & Policy (DIOP). DIOP has direct reference authority for detention without physical examination of these medical gloves. Violative medical gloves are subject to RPM Chapter 9, Detention Without Physical Examination, subchapter Recommendations Based on One Sample.

The following strategy has been established to address those manufacturers/shippers who are found to repeatedly ship violative medical gloves to the U.S. (recidivist firms.)

*** Level 1 Detention (INDICATED BY * on the Red List) ***

When the CDRH encounters a shipment of medical gloves which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIOP, HFC-170.

If the recommendation meets current guidance, the manufacturer/shipper will be placed on the Red List with a single asterisk (*) in the notes field, and subsequent medical glove shipments from that manufacturer/shipper may be detained without physical examination under this import alert. This is referred to as Level 1 detention. The manufacturer/shipper may obtain admission of subsequently detained shipments of medical gloves by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory, following sampling plan and test method contained in FDA guidance.

*** In order for the responsible manufacturer's/shipper's name to be removed from the Red List, documentation should be provided with sufficient evidence that their medical gloves are not adulterated (for example, five consecutive non-violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for manufacturers/shippers to be removed from Level 1 detention). **

Sri Trang Gloves (Thailand) Co., Ltd.
Date Published : 08/04/2021
109/2 Kanjanavanit Road , Hat Yai, Songkhla THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YY Glove, Patient Examination, Latex
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 Q - - DO Fentanyl and other opioid protection glove
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1

BESTSAFE GLOVE CO.,LTD
Date Published : 12/08/2021
52/43 Watkodhin-Kaophai Rd. , T.Tubma , A.Muang Rayong, RAYONG THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 12/08/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YY Glove, Patient Examination, Latex
Date Published: 12/08/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 12/08/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 12/08/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 12/08/2021
Desc: Examination Gloves
Notes: *Level 1

Medical Glove Company Limited
Date Published : 10/26/2021
268. Moo 7. Tampom Lam Thap. , Amphur Lam Tham , Krabi, THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 10/26/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YY Glove, Patient Examination, Latex
Date Published: 10/26/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 10/26/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 10/26/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 10/26/2021
Desc: Examination Gloves
Notes: *Level 1

PADDY THE ROOM TRADING CO LTD
Date Published : 08/04/2021
Prakanong , 1112/25 Sukhumvit Rd , Khlong Toei, Bangkok THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YY Glove, Patient Examination, Latex
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 Q - - DO Fentanyl and other opioid protection glove
Date Published: 08/04/2021
Desc: Examination Gloves

SUFFICIENCY ECONOMY CITY CO LTD
Date Published : 08/04/2021
86 Ratchadaphisek Road , Bangkok, THAILAND
80 F - - MC Glove, Patient Examination
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YY Glove, Patient Examination, Latex
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - YZ Glove, Patient Examination, Vinyl
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZA Glove, Patient Examination, Poly
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 L - - ZC Glove, Patient Examination, Specialty
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1
80 Q - - DO Fentanyl and other opioid protection glove
Date Published: 08/04/2021
Desc: Examination Gloves
Notes: *Level 1