(183 days)
Not Found
No
The device is a protective gown and the description focuses on material properties and barrier performance, with no mention of AI or ML.
No
The device is a protective gown intended to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
Explanation: The device is a protective gown, which is a barrier intended to prevent the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly states it is a physical protective gown made of chlorinated polyethylene elastomer non-woven tri-laminate, and the performance studies focus on physical barrier properties and material characteristics. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and barrier performance of the gown. It does not mention any components or processes related to testing samples from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and barrier properties of the gown (liquid resistance, strength, flammability, biocompatibility), not on diagnostic accuracy or performance.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This protective gown does not fit that definition.
N/A
Intended Use / Indications for 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 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.
Product codes
OPC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical performance data was evaluated. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown underwent testing including: AAMI PB70:2012 (Overall barrier performance), Hydrostatic Pressure Test (AATCC 127:2018) (Resistance to static liquid), Impact Penetration (AATCC 42-2017) (Resistance to liquid stream), ASTM D 3776 - Mass/unit area (Basis weight of material), ASTM D5034 Breaking Strength - Grab Test (Durability: Grab test), ASTM D5587 Tear Strength - Trapezoid Test (Durability: Trapezoid), 16 CFR 1610 - Flammability (Flammability), ISO 10993-5 (Cytotoxicity), and 10993-10 Sensitization/Irritation (Biocompatibility: Sensitization and irritation). All tests passed, confirming that the design inputs and performance specifications are met. Clinical performance data was not used.
Key Metrics
AAMI PB70:2012: Pass (Meet requirements for classification as AAMI PB70 Level 3 gown)
Hydrostatic Pressure Test (AATCC 127:2018): Pass (NLT 50.0 cm H2O)
Impact Penetration (AATCC 42-2017): Pass (No penetration)
ASTM D 3776 - Mass/unit area: Pass (26 g/m²)
ASTM D5034 Breaking Strength - Grab Test: Pass (Length – 27 N, Width – 31.5 N)
ASTM D5587 Tear Strength - Trapezoid Test: Pass (Length – 10.5 N, Width 14.0 N)
16 CFR 1610 - Flammability: Pass (Class 1)
ISO 10993-5 Cytotoxicity: Pass (Under the conditions of the study, non-cytotoxic)
10993-10 Sensitization/Irritation: Pass (Under the conditions of the study, not a sensitizer; Under the conditions of the study, non-irritating)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | X |
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."
3
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: Robert@QPMconsult.com Direct number: (940) 390-0961
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
High Barrier Protection |
|------------------------|---------------------------------------------------------------------------------------------------|
| Regulation Description | Surgical Apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | QPC: Gown, Non-sterile, Non-Isolation, Intended to provide
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
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
4
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,
Single Use, Non-Sterile,
Protective Gown | BAM Corporation
SafeCare Open Back
Protective Gowns | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K211538 | K160337 | - |
| Product Code | QPC | QPC | Same |
| Regulation
Number | 878.4040 | 878.4040 | Same |
| Indications For
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 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, | These gowns are intended to
protect both health care
patients and health care
personnel from the transfer of
microorganisms, body fluids
and particulate material. The
back of the gown is open and
non-protective. They are not
intended for use in the
operating room. | Similar |
Table 1 – Comparison AZAC Level 3 Gown vs BAM Corp Gown
5
| | Single Use, Non-Sterile,
Protective Gown is a single use,
disposable medical device and
is provided non-sterile. | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Material
Composition | Chlorinated polyethylene
elastomer (CPE) | Extruded from plastic film | Similar. |
| AAMI PB70
Barrier
Protection Level | Level 3 | Level 3 | Same |
| Design Features | Over-the-head slip on
Integrated Belt Ties
Thumbhook cuffs | Open back, thumb loops,
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
study, non-cytotoxic
Under the conditions of the
study, not a sensitizer
Under the conditions of the
study, non-irritating | Under the conditions of the
study, non-cytotoxic
Under the conditions of the
study, not a sensitizer
Under the conditions of the
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 | |
| classification as AAMI | |||
| PB70 Level 3 gown | Pass | ||
| Hydrostatic Pressure | |||
| Test (AATCC | |||
| 127:2018) | Resistance to static liquid | NLT 50.0 cm H2O | Pass |
| Impact Penetration | |||
| (AATCC 42-2017) | Resistance to liquid stream | No penetration | Pass |
| ASTM D 3776 - | |||
| Mass/unit area | Basis weight of material | 26 g/m² | Pass |
| ASTM D5034 | |||
| Breaking Strength - | |||
| Grab Test | Durability: Grab test | Length – 27 N | |
| Width – 31.5 N | Pass | ||
| ASTM D5587 | |||
| Tear Strength - | |||
| Trapezoid Test | Durability: Trapezoid | Length – 10.5 N | |
| Width 14.0 N | Pass | ||
| 16 CFR 1610 - | |||
| Flammability | Flammability | Class 1 | Pass |
Table 2 – Non-clinical performance testing
6
| ISO 10993-5
Cytotoxicity | Biocompatibility:
Cytotoxicity potential | Under the conditions of
the study, non-cytotoxic | Pass |
|---------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| 10993-10
Sensitization/
Irritation | Biocompatibility:
Sensitization and irritation | Under the conditions of
the study, not a sensitizer
Under the conditions of
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)