← Product Code [FYA](/productcode/FYA) · K260725

# BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (K260725)

_Hindernis DE Mexico, S.A.P.I. DE C.V. · FYA · May 12, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260725

## Device Facts

- **Applicant:** Hindernis DE Mexico, S.A.P.I. DE C.V.
- **Product Code:** [FYA](/productcode/FYA.md)
- **Decision Date:** May 12, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Indications for Use

The BAÜMER Surgical Gowns (COP01, COP04, COP05, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile.

## Device Story

Single-use, disposable, sterile surgical gowns (models COP01, COP04, COP05, COP10); worn by healthcare professionals in clinical settings; provides Level 4 liquid barrier protection per ANSI/AAMI PB70; constructed with raglan sleeves, hook and loop neck closures, and tie waist closures; materials include SMMS nonwoven, BVB, polyester, and PE/SPP; sterilized via Co 60 radiation; protects against transfer of microorganisms, body fluids, and particulates.

## Clinical Evidence

No clinical data. Bench testing only. Performance verified via AATCC 127 (water resistance), ASTM F1671 (blood-borne pathogen penetration), ASTM D5034 (tensile strength), ASTM D5733 (tearing strength), ISO 9073-10 (linting), ASTM D1683 (seam strength), 16 CFR 1610 (flammability), and ISO 10993 series (biocompatibility).

## Technological Characteristics

Materials: SMMS nonwoven, BVB, polyester, PE/SPP. Design: Full length, raglan sleeves, hook/loop neck, tie waist. Protection: ANSI/AAMI PB70 Level 4. Sterilization: Co 60 radiation (SAL 10^-6). Standards: ASTM D5034, ASTM D5733, ASTM D1683, ASTM F1671, AATCC 127, ISO 10993, 16 CFR 1610.

## Regulatory Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

## Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

## Predicate Devices

- AERO CHROME Breathable Performance Surgical Gowns ([K200522](/device/K200522.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 12, 2026

Hindernis DE Mexico, S.A.P.I. DE C.V.
% Charles Shen
Vice President
Manton Business and Technology Services
37 Winding Ridge
Oakland, New Jersey 07436

Re: K260725
Trade/Device Name: BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FYA
Dated: March 5, 2026
Received: March 5, 2026

Dear Charles Shen:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K260725 - Charles Shen
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

{2}

K260725 - Charles Shen
Page 3

Sincerely,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K260725  |   |
|  Device Name BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)  |   |
|  Indications for Use (Describe) BAÜMER Surgical Gowns (COP01, COP04, COP05, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile.  |   |
|  Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C)  |   |
|  CONTINUE ON A SEPARATE PAGE IF NEEDED.  |   |
|  This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*  |   |
|  The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."  |   |

{4}

K260725/ Hindernis de México S.A.P.I. de C.V.

# K260725

## 510(k) Summary:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92

## 1.0 Submitter Information

Hindernis de México S.A.P.I. de C.V.
Carr. Naucalpan Ixlahuaca No. 58, Col. Barrio de la Rosa
Naucalpan De Juárez, Estado de México, CP 53216 México
TEL: (052) 55-17414202

## Submission Correspondent

![img-0.jpeg](img-0.jpeg)

Chengyu (Charles) Shen
Manton Business and Technology Services
37 Winding Ridge,
Oakland, NJ 07436
Tel: 608-217-9358
Email: cyshen@aol.com

Jinfeng Ning
Manton Business and Technology Services
37 Winding Ridge,
Oakland, NJ 07436
Tel: 1-504-256-3616
Email: jfning@gmail.com

Date of Summary: April 09, 2026

## 2.0 Device Information

Proprietary Name: BAÜMER Surgical Gowns (COP01, COP04, COP05, and COP10)
Device Common Name: Gown, Surgical
Classification Name: Gown, Surgical
Classification Regulation: 878.4040
Class: Class 2
Panel: General Hospital
Product Code: FYA

1 / 6

{5}

K260725/ Hindernis de México S.A.P.I. de C.V.

# 3.0 Predicate Device Information:

The BAÜMER Surgical Gowns (COP01, COP04, COP05, and COP10) described in this premarket notification are substantially equivalent to the following device:

(1) K200522, “AERO CHROME Breathable Performance Surgical Gowns”, manufactured by “O & M Halyard Inc” located in Mechanicsville, VA, USA.

# 4.0 Device description:

BAÜMER Surgical Gowns have four different models, which are: COP01, COP04, COP05, and COP10

- COP01: Surgical Gown
- COP04: Ultra Breathable Surgical Gown
- COP05: High Performance Surgical Gown
- COP10: Surgical Gown for Surgical Assistant

They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures.

Model COP01 and Model COP10 are made from SMMS Repellent 43 Gram material at the chest and sleeve area (critical zone), while Model COP04 is made from BVB 60 Gram material at the chest and sleeve area (critical zone). Model COP05 is made from BVB 60 Gram material at the sleeve area, and SMMS Repellent 43 Gram material, enforced with PP/PE material at the chest area.

All models provide Level 4 protection per ANSI/AAMI PB70 standard.

BAÜMER Surgical Gown, Models COP01, COP04, COP05, and COP10 have four different sizes: Large (L), Extra Large (XL), and Extra Extra Large (XXL), and Super Extra large (XXXL).

All gowns are sterilized with Co 60 radiation.

# 5.0 Indications for Use:

The BAÜMER* SURGICAL GOWNS (COP01, COP04, COP05, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile

2 / 6

{6}

# 6.0 Comparison to Predicate Devices

The BAUMER Surgical Gowns (COP01, COP04, COP05, and COP10) described in this premarket notification are compared to the following device:

(1) K200522, "AERO CHROME Breathable Performance Surgical Gowns", manufactured by "O & M Halyard Inc" located in Mechanicsville, VA, USA.

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

Table 1: Comparison of Intended Use, Design, and Material

|  Description | Subject Device | Predicate Device (K200522) | Comparison Analysis  |
| --- | --- | --- | --- |
|  Product Code | FYA | FYA | Same  |
|  Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same  |
|  Classification | Class 2 | Class 2 | Same  |
|  Indication for Use | The BAUMER* SURGICAL GOWNS (COP01, COP04, COP05, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile | AERO CHROME* Breathable Performance Surgical Gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The AERO CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70 Liquid Barrier classifications. | Similar  |
|  Basic Design | Full length, constructed with raglan sleeves, neck closures, and waist closures. | Full length, constructed with raglan sleeves, neck closures, and waist closures. | Same  |
|  Features | Regular and Reinforced | Regular and Reinforced | Same  |
|  Materials | SMMS nonwoven, BVB, Polyester, PE/SPP | SMS nonwoven, Polyester and Polyamide | Similar  |
|  Protection Level | Level 4 per ANSI/AAMI PB70 | Level 4 per ANSI/AAMI PB70 | Same  |

K260725/ Hindernis de México S.A.P.I. de C.V.

{7}

The subject device and predicate device are similar in use, design, and material. The minor differences between the subject device and predicate device do not raise any concerns in terms of safety and effectiveness.

The following table shows similarities and differences of performances between our device and the predicate device.

Table 2: Comparison of Device Performance

|  Description | Subject Device | Predicate Device (K200522) | Comparison Analysis  |
| --- | --- | --- | --- |
|  ANSI/AAMI PB70 | Level 4 Liquid Barrier for Critical ZoneLevel 4 Liquid Barrier for Non-Critical ZoneLevel 4 Liquid Barrier for Sleeve SeamLevel 4 Liquid Barrier for Shoulder SeamLevel 4 Liquid Barrier for tie attachment area | Level 4 Liquid Barrier for Critical ZoneLevel 1 Liquid Barrier for Non-Critical Zone | Better than Predicate device  |
|  Biocompatibility Per ISO 10993-1 | Under the conditions of the study: non-cytotoxic, non-irritant, and non-sensitizing | Under the conditions of the study: non-cytotoxic, non-irritant, and non-sensitizing | Identical  |
|  Water Vapor Transmission Rate of Materials (MOCON) | Not performed | Pass | This is not a mandatory test  |
|  Linting per ISO 9073-10 | Average ≤ 10000 (Log L < 4.0) | Pass | Similar  |
|  Tensile/ Breaking Strength and Elongation per ASTM D5034 | PassMD Mean ≥ 10 N;CD Mean ≥ 10 N | Pass | Identical  |

K260725/ Hindernis de México S.A.P.I. de C.V.

{8}

K260725/ Hindernis de México S.A.P.I. de C.V.

|  Tearing Strength per ASTM D5733-99 | Pass: MD Mean ≥ 30 N; CD Mean ≥ 30 N | N/A | Not reported by predicate device  |
| --- | --- | --- | --- |
|  Seam Strength per ASTM D1683 | ≥ 30 N | N/A | Not reported by predicate device  |
|  Peel Strength per STM-00197 | Not performed | Pass | This is not a mandatory test  |
|  Hydrohead Testing | Not performed | Pass | This is not a mandatory test  |
|  Abrasion Testing per STM-00149 | Not performed | Pass | This is not a mandatory test  |
|  Flammability of Clothing Textiles per 16 CFR Chapter II | Class 1 | Class 1 | Identical  |
|  Air Permeability (Back of Gown) per STM-00162 | Not performed | Pass | This is not a mandatory test  |
|  SAL | 10^{-6} | 10^{-6} | Identical  |
|  Sterilization Modality | Radiation | EtO | Similar  |

## 7.0 Non-Clinical Study Summary

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

Table 3: Summary of Non-Clinical Studies

|  Test Standard | Purpose | Acceptance Criteria | Results  |
| --- | --- | --- | --- |
|  AATCC127 | Water resistance/Hydrostatic Pressure | ≥ 50 cm for critical zone ≥ 50 cm for non-critical zone ≥ 50 cm for sleeve seam ≥ 50 cm for shoulder seam ≥ 50 cm for tie attachment area | Pass  |

5 / 6

{9}

|  ASTM F1671 | Resistance to Penetration by Blood Born Pathogen | No Penetration for critical zone No Penetration for non-critical zone No Penetration for sleeve seam No Penetration for shoulder seam No Penetration for tie attachment area | Pass  |
| --- | --- | --- | --- |
|  ASTM D5034-09 | Tensile Strength | MD Mean ≥ 30 N; CD Mean ≥ 30 N | Pass  |
|  ASTM D5733-99 | Tearing Strength | MD Mean ≥ 10 N; CD Mean ≥ 10 N | Pass  |
|  ISO 9073-10 | Linting | Average ≤ 10000 (Log L < 4.0) | Pass  |
|  ASTM D1683 | Seam Strength | ≥ 30 N | Pass  |
|  16 CFR 1610 | Flammability testing | Meet CPSC 1610 Class 1 | Pass  |
|  ASTM F88 | Sterile barrier seal strength | > 60 N | Pass  |
|  ASTM F1929 | Sterile barrier dye penetration | No penetration | Pass  |
|  ISO 10993-5 | In vitro cytotoxicity | Under conditions of the study, not cytotoxic | Pass  |
|  ISO 10993-23 | Irritation | Under the conditions of the study, not an irritant | Pass  |
|  ISO 10993-10 | Skin sensitization | Under conditions of the study, not a sensitizer | Pass  |
|  ISO 11137/ ISO 13004 | Sterilization Validation | SAL level of 10^{-6} | Pass  |

## 8.0 Clinical Study Summary

Clinical study was not performed for this product.

## 9.0 Conclusion

The conclusions drawn from the nonclinical tests that demonstrate is that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.

K260725/ Hindernis de México S.A.P.I. de C.V.

---

**Source:** [https://fda.innolitics.com/device/K260725](https://fda.innolitics.com/device/K260725)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com