Protect X Level 3 Isolation Gown

K211538 · Azac Group · FYC · Nov 17, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211538
• Device Name: Protect X Level 3 Isolation Gown
• Applicant: Azac Group
• Product Code: FYC · General, Plastic Surgery
• Decision Date: Nov 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

Device Story

Protective gown for moderate-risk clinical environments; used by healthcare personnel to prevent transfer of microorganisms, body fluids, and particulates. Device is single-use, disposable, non-sterile, and worn over clothing. Constructed from chlorinated polyethylene (CPE) elastomer non-woven tri-laminate. Features over-the-head design, integrated belt ties, and thumbhook cuffs. Provides AAMI Level 3 barrier protection. Clinical benefit includes reduced exposure to contaminants during routine procedures like IV insertion or blood draws. Not intended for surgical or operating room use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including AAMI PB70:2012 barrier performance, AATCC 127 hydrostatic pressure, AATCC 42 impact penetration, ASTM D3776 mass/unit area, ASTM D5034 breaking strength, ASTM D5587 tear strength, 16 CFR 1610 flammability, and ISO 10993-5/10 biocompatibility testing.

Technological Characteristics

Material: Chlorinated polyethylene (CPE) elastomer non-woven tri-laminate. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Physical specs: 26 g/m² basis weight; grab strength (27N length/31.5N width); trapezoid tear strength (10.5N length/14.0N width). Flammability: Class 1 per 16 CFR 1610. Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating per ISO 10993-5/10. Design: Over-the-head, integrated belt ties, thumbhook cuffs.

Indications for Use

Indicated for health care personnel and patients to provide protection against transfer of microorganisms, body fluids, and particulate material in moderate risk settings (e.g., venous blood draws, IV insertion, emergency room). Not for use in operating rooms.

Regulatory Classification

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

• BAM Corporation - Safe Care open Care Protective Gowns and ValueCare Open Back Protective Gowns (K160337)

Submission Summary (Full Text)

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November 17, 2021

AZAC Group Robert Seiple President QPM Consulting, LLC 3817 Seville Rd Denton, Texas 76205

Re: K211538

Trade/Device Name: AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: October 8, 2021 Received: October 13, 2021

Dear Robert Seiple:

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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211538

#### Device Name

AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

Indications for Use (Describe)

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-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) | <span style="text-decoration: overline;">X</span> |

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# 510(k) Summary K211538

AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

# 1. Submission Sponsor

AZAC Group 17870 Castleton St., Suite 121 City of Industry, CA, 91748 USA Contact: Yen Ping Shan Title: COO

## 2. Submission Correspondent

Robert Seiple, RAC President, QPM Consulting, LLC Email: [e-mail] Direct number: [phone]

## 3. Date Prepared

16 November 2021

#### 4. Device Identification

Type of 510(k) Submission: Traditional

| Device: | Gown, Non-Sterile, Non-Isolation, intended to Provide Moderate or<br>High Barrier Protection |
|------------------------|---------------------------------------------------------------------------------------------------|
| Regulation Description | Surgical Apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | QPC: Gown, Non-sterile, Non-Isolation, Intended to provide<br>Moderate or High Barrier Protection |
| Class: | Class 2 |
| Panel: | General Hospital |

Trade or Proprietary Name: AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown

#### 5. Legally Marketed Predicate Device(s)

| Device name: | BAM Corporation - Safe Care open Care Protective Gowns and<br>ValueCare Open Back Protective Gowns |
|----------------|----------------------------------------------------------------------------------------------------|
| 510(k) number: | K160337 |
| Manufacturer: | BAM Corporation |

#### 6. Indication for Use Statement

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and

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particulate material. Not intended for use in the operating room

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

# 7. Device Description

The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is used in moderate risk situations such as venous blood draws, inserting IVs, and emergency room use. The gown is not sterile; is not an isolation gown and is not indicated for use in the Operating Room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is made of one-piece chlorinated polyethylene elastomer non-woven tri-laminate. The Level 3 gown meets the ANSI/ AAMI PB70 Level 3 standards. The gown is a single use, disposable device.

# 8. Comparison of Technological Characteristics with the Predicate Device

The following table compares the AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown to the BAM Corporation SafeCare Open Back Protective Gowns (K160337).

| Attribute | AZAC Protect X Level 3,<br>Single Use, Non-Sterile,<br>Protective Gown | BAM Corporation<br>SafeCare Open Back<br>Protective Gowns | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K211538 | K160337 | - |
| Product Code | QPC | QPC | Same |
| Regulation<br>Number | 878.4040 | 878.4040 | Same |
| Indications For<br>Use | The AZAC Protect X Level 3,<br>Single Use, Non-Sterile,<br>Protective Gown is intended to<br>protect health care personnel<br>and patients from the transfer<br>of microorganisms, body fluids<br>and particulate material. Not<br>intended for use in the<br>operating room<br>The AZAC Protect X Level 3,<br>Single Use, Non-Sterile,<br>Protective Gown meets the<br>barrier protection requirements<br>of AAMI Level 3 per ANSI/AAMI<br>PB70:2012 — Liquid Barrier<br>Performance and Classification<br>of Protective Apparel and<br>Drapes Intended for Use in<br>Health Care Facilities.<br>The AZAC Protect X Level 3, | These gowns are intended to<br>protect both health care<br>patients and health care<br>personnel from the transfer of<br>microorganisms, body fluids<br>and particulate material. The<br>back of the gown is open and<br>non-protective. They are not<br>intended for use in the<br>operating room. | Similar |

# Table 1 – Comparison AZAC Level 3 Gown vs BAM Corp Gown

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| | Single Use, Non-Sterile,<br>Protective Gown is a single use,<br>disposable medical device and<br>is provided non-sterile. | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Material<br>Composition | Chlorinated polyethylene<br>elastomer (CPE) | Extruded from plastic film | Similar. |
| AAMI PB70<br>Barrier<br>Protection Level | Level 3 | Level 3 | Same |
| Design Features | Over-the-head slip on<br>Integrated Belt Ties<br>Thumbhook cuffs | Open back, thumb loops,<br>perforated back. | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Color | Blue and Yellow | Blue and Yellow | Same |
| Biocompatibility | Under the conditions of the<br>study, non-cytotoxic<br>Under the conditions of the<br>study, not a sensitizer<br>Under the conditions of the<br>study, non-irritating | Under the conditions of the<br>study, non-cytotoxic<br>Under the conditions of the<br>study, not a sensitizer<br>Under the conditions of the<br>study, non-irritating | Same |

# 9. Non-Clinical Performance Data

To demonstrate the safety and effectiveness of AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown and to show substantial equivalence to the predicate device, AZAC Group completed the following non-clinical tests listed in the following table. Results confirm that the design inputs and performance specifications are met. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown passed the following tests in accordance with internal requirements and applicable standards as shown below:

| Test Method | Purpose | Criteria | Result |
|--------------------------------------------------|-----------------------------|----------------------------------------------------------------------|--------|
| AAMI PB70:2012 | Overall barrier performance | Meet requirements for<br>classification as AAMI<br>PB70 Level 3 gown | Pass |
| Hydrostatic Pressure<br>Test (AATCC<br>127:2018) | Resistance to static liquid | NLT 50.0 cm H2O | Pass |
| Impact Penetration<br>(AATCC 42-2017) | Resistance to liquid stream | No penetration | Pass |
| ASTM D 3776 -<br>Mass/unit area | Basis weight of material | 26 g/m² | Pass |
| ASTM D5034<br>Breaking Strength -<br>Grab Test | Durability: Grab test | Length – 27 N<br>Width – 31.5 N | Pass |
| ASTM D5587<br>Tear Strength -<br>Trapezoid Test | Durability: Trapezoid | Length – 10.5 N<br>Width 14.0 N | Pass |
| 16 CFR 1610 -<br>Flammability | Flammability | Class 1 | Pass |

# Table 2 – Non-clinical performance testing

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| <b>ISO 10993-5<br/>Cytotoxicity</b> | Biocompatibility:<br>Cytotoxicity potential | Under the conditions of<br>the study, non-cytotoxic | Pass |
|---------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| <b>10993-10<br/>Sensitization/<br/>Irritation</b> | Biocompatibility:<br>Sensitization and irritation | Under the conditions of<br>the study, not a sensitizer<br>Under the conditions of<br>the study, non-irritating | Pass |

# 10. Clinical Performance Data

Clinical performance data was not used in support of this evaluation.

# 11. Statement of Substantial Equivalence

The conclusions drawn from the non-clinical testing demonstrate that the AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate SafeCare Open Back Protective Gowns (K160337)