50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Surgical Gowns

standard surgical gown

SURGICAL GOWN, Standard

Surgical gown

Device Name

Non-sterile Surgical Gowns

Model / Reference

MCC1006SA, MCC1003SA, 61.35.04ZD, MCC1008SA, 11.35.01ZD, 250029B, 61.35.05ZD, 61.30.02ZD, MCC7014SA, 250027B, AGSXL-1, 11.30.06ZD, 11.35.03ZD, MCC9016SA, 250030B, 1291010, 11.30.03ZD, ACGSXL, 18112-1, 61.30.01ZD, MCC11018SA, MCC6013SA, AGSL/1291000, 11.30.01ZD, Z564B124002S, 61.30.06ZD, ZD200046B1014, ZDB120026-1, 1291012, 61.35.02ZD, ACGSXL-1, 18113-1, 1291011, MCC1004SA, 11.35.04ZD, 250028B, 11.35.05ZD, ACGSXLL

Primary DI / UDI-DI

06931747841998, 06931747841936, 06931747830190, 06931747842032, 06931747830046, 06931747830626, 06931747830206, 06931747823758, 06931747842117, 06931747830565, 06971004787416, 06931747823727, 06931747830084, 06931747842155, 06931747830657, 06971004785757, 06931747823666, 06931747807727, 06931747838639, 06931747823741, 06931747842193, 06931747842094, 06971004785665, 06931747823628, 06931747843527, 06931747830237, 06931747838684, 08436596000063, 06931747800049, 06931747830176, 06931747807741, 06931747838646, 06931747800032, 06931747841950, 06931747830107, 06931747830596, 06931747830121, 06931747807765

Basic UDI-DI

69317478SSG0000029E, 69317478SSG0000019C, 69317478NSSG00000124

510(k) Number

K192290 ↗

FDA Product Code

FYA

EMDN Code

T020402, T020401

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 878.4040

EU market of registration

Czechia

Northern Ireland

Germany

Spain

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Drape, patient, bi

  Class I

  CE/MDR

• standard surgical gown

  Class I

  CE/MDR

• Drape

  Class I

  CE/MDR

• Instrument Bag

  Class I

  CE/MDR

• Surgical Gown Primary SP L-L

  Class I

  CE/MDR

• Side Drape

  Class I

  CE/MDR

See all devices from Xuchang Zhengde Environstar Medical Products Co., Ltd. →

• What types of barrier protection do these surgical gowns provide, and how are they differentiated?

  These gowns offer varying levels of liquid barrier protection as defined by ANSI/AAMI PB70:2012. The 50g SMS Standard Surgical Gown provides basic protection, while the 45g SMS Surgical Gown with Reinforcement meets Level 3 standards. The 68g BVB Surgical Gown and 68g BVB Splicing Surgical Gown achieve Level 4 protection, the highest among the four variants, making them ideal for procedures with higher fluid exposure risks.

• Are these gowns reusable, and if not, what makes them suitable for single-use?

  No, these gowns are explicitly designed for single-use in clinical surgical settings. Their sterile supply and barrier protection engineering (including reinforced or layered materials like SMS and BVB) ensure they maintain integrity for one procedure only, reducing contamination risks. Reuse would compromise sterility and performance.

• How do I determine which gown weight or variant is best for my surgical procedures?

  Choose based on the expected fluid exposure and procedural demands: the 50g SMS Standard is lightweight for low-risk settings, while the 45g SMS with Reinforcement adds durability for moderate fluid exposure. For high-risk procedures (e.g., complex surgeries with splashing), the 68g BVB variants—especially the splicing model—offer superior Level 4 protection against liquids and particulates. Always align selection with your facility’s infection control protocols.

• Do these gowns require special storage conditions, or can they be kept in standard surgical supply rooms?

  The manufacturer does not specify storage instructions, but compliance with FDA 510(k) clearance (K192290) and MDR standards ensures their suitability for standard surgical environments. Store in a cool, dry place away from direct sunlight or extreme temperatures to preserve barrier integrity. Avoid humidity or chemical exposure, as these could degrade material performance.

• What regulatory pathways have these gowns followed, and how does that affect their use in clinical settings?

  These gowns have undergone FDA 510(k) clearance (K192290) under the Traditional pathway, with a Substantially Equivalent determination by the Surgical Devices Panel (SU). They also comply with EU MDR, ensuring they meet both U.S. and European regulatory standards for surgical apparel. Their clearance confirms they meet performance requirements for barrier protection, making them suitable for use in certified operating rooms worldwide.