510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PT. Sintong Unigolden Glove

KISARAN Sumatera Utara, ID

PT. SINTONG UNIGOLDEN GLOVE appears in FDA device records in KISARAN Sumatera Utara, ID. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for PT. Sintong Unigolden Glove in 2022.

Clearances by year, as a table
510(k) clearance decisions for PT. Sintong Unigolden Glove, by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223235Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)LZASubstantially Equivalent

Registered establishments

FDA registered establishments for PT. Sintong Unigolden Glove, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30253039653025303965PT. SINTONG UNIGOLDEN GLOVEJL. LINTAS SUMATERA, HESSA PERLOMPONGAN, KISARAN Sumatera Utara 21272 ID2026

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

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