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Isolation Gown S

EUDAMEDFDA UDI

Class I (EU MDR)

Ref HY1-50027Model Isolation and Surgical gownsRef HY1-50041

by Hygitech

Identity

Trade Name
Isolation Gown S EUDAMED
HYGITECH FDA UDI
Generic Name
Surgical gown, single-use FDA UDI
Device Name
Isolation and Surgical gowns EUDAMED
Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available in 4 sizes for the best fit: S, M, L, XL EO sterilised with a 3 year shelf-life FDA UDI
Model / Reference
Isolation and Surgical gowns EUDAMED
HY1-50027 EUDAMED
HY1-50041 EUDAMED
HY-50027 FDA UDI
Description
Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m². Available in 4 sizes for the best fit: S, M, L, XL EO sterilised with a 3 year shelf-life FDA UDI

Identifiers

Catalog Number
HY-50027 FDA UDI
Primary DI / UDI-DI
03615140002110 EUDAMEDFDA UDI
03615140006514 EUDAMED
Basic UDI-DI
361514H2PRIN112WJ EUDAMED
510(k) Number
K121152 FDA UDI
FDA Product Code
FYA FDA UDI
EMDN Code
T020401 STANDARD SURGICAL GOWNS EUDAMED
GMDN Term
Surgical gown, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Isolation Gown S by Hygitech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hygitech
EUDAMED SRN
FR-MF-000007549

Sources (3)

  • EUDAMED 89ae2c4b-ce6c-4675-8902-1dbd3291e860 61 fields · synced Jul 25, 2026
  • FDA UDI bd89bbe6-7a37-46a9-811d-71f67afac371 35 fields · synced May 30, 2026
  • EUDAMED 3f7d05a8-b8ed-4df5-9757-f8ae97a35f1b 61 fields · synced Jul 25, 2026