510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Careglove Global Sdn Bhd

Seremban Negeri Sembilan, MY

CAREGLOVE GLOBAL SDN BHD appears in FDA device records in Seremban Negeri Sembilan, MY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Careglove Global Sdn Bhd between 2017 and 2025. The busiest year on record is 2022, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Careglove Global Sdn Bhd, by decision year
YearClearances
20172
20191
20223
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250578Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)LZASubstantially Equivalent
K230121Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)LZASubstantially Equivalent
K220859Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)LZASubstantially Equivalent
K213993Powder Free Chloroprene Examination Glove Coloured (Blue, Green)LZASubstantially Equivalent
K211666Powder Free Nitrile Examination Gloves, Blue ChemotestLZASubstantially Equivalent
K190241Sterile Latex Surgical Glove, Powder FreeKGOSubstantially Equivalent
K172015POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)LZASubstantially Equivalent
K161833LATEX EXAMINATION GLOVE POWDER FREELYYSubstantially Equivalent

Registered establishments

FDA registered establishments for Careglove Global Sdn Bhd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30141647343014164734CAREGLOVE GLOBAL SDN BHDLot 17479, Lorong Senawang 3/2,, Seremban Negeri Sembilan 70450 MY2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain