Facility

ANSELL (THAILAND) LTD.

6 recall(s) on record — most severe on record: Class II.

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002806370
Establishment type	Manufacture Medical Device
Location	74 SOI CHALONGKRUNG 31 THAILAND Krung Thep Maha Nakhon, TH 10520
Registration status	Active · expires 2026
Parent company	ANSELL HEALTHCARE PRODUCTS LLC (owner-operator 8020065)

Activity by year

Recalls (6)

Devices registered here (3)

Polymer Patient Examination Glove
Product code LZA (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250
Fentanyl And Other Opioid Protection Glove
Product code QDO (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250
Medical Glove, Specialty
Product code LZC (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6250

Recalls & enforcement

Class IIOngoing2023-08-03
Some surgical glove sterile pouches were not completely sealed.
Class IIOngoing2022-02-19
Transport company failed to stop at the border for required FDA inspection.
Class IITerminated2020-08-19
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Class IITerminated2016-10-24
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Class IITerminated2013-01-14
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints conc…
Class IITerminated2012-11-05
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ANSELL (THAILAND) LTD. (FEI 3002806370) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806370-ansell-thailand-ltd/

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