Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K231408

by Shandong Intco Medical Products Co., Ltd.

Identifiers

510(k) Number: K231408 FDA 510(k)
FDA Product Code: LZA FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 880.6250 FDA 510(k)
Regulation Number: 880.6250 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile by Shandong Intco Medical Products Co., Ltd. — Class I — MDR, FDA_510K — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K231408	Class I	Active

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Manufacturer

Manufacturer: Shandong Intco Medical Products Co., Ltd.
FDA Applicant: Shandong Intco Medical Products Co, Ltd.

Sources (2)

FDA 510(k) K231408 24 fields · synced Oct 8, 2026
EUDAMED 1 fields · synced May 19, 2026