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Satin Dams

FDA UDI

Class II (US FDA UDI)

by Global Protection Corp.

Identity

Trade Name
Satin Dams FDA UDI
Generic Name
Oral/vaginal sex barrier, Hevea-latex FDA UDI
Device Name
Latex Prophylactic Oral Dam FDA UDI
Model / Reference
LGPMX12E FDA UDI
Description
Latex Prophylactic Oral Dam FDA UDI

Identifiers

Primary DI / UDI-DI
00726893115101 FDA UDI
510(k) Number
K990067 FDA UDI
FDA Product Code
MSC FDA UDI
GMDN Term
Oral/vaginal sex barrier, Hevea-latex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/vaginal sex barrier, Hevea-latex

Satin Dams by Global Protection Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/vaginal sex barrier, Hevea-latex.

Cleared under the same submission

K990067 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Global Protection Corp.

Sources (1)

  • FDA UDI 30ec297a-6bee-45dc-bfd4-badcbcbb3729 35 fields · synced Jun 6, 2026