510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Shandong Jieshi Medical Products Co.,Ltd

Heze City Shandong, CN

SHANDONG JIESHI MEDICAL PRODUCTS CO.,LTD appears in FDA device records in Heze City Shandong, CN. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Shandong Jieshi Medical Products Co.,Ltd in 2021.

Clearances by year, as a table
510(k) clearance decisions for Shandong Jieshi Medical Products Co.,Ltd, by decision year
YearClearances
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K210777Powder Free Nitrile Patient Examination Gloves, Blue ColorLZASubstantially Equivalent
K210774Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)LYZSubstantially Equivalent

Registered establishments

FDA registered establishments for Shandong Jieshi Medical Products Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30158750063015875006Shandong Jieshi Intelligent Technology Co., Ltd.N. of Rd., 200M. from the cross of Hanjiang Rd. and Qinghe Mid-Rd., Qinghe St., Caoxian, Heze City Shandong 274400 CN2026

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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What MDM checks, and what it does not

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