The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

Device Description

The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps.

The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown.

The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.

AI/ML Overview

The provided document is a 510(k) summary for a medical device: Unico Global Level 3 Surgical Gown. It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. This document does NOT contain information about an AI/ML powered device, nor does it contain a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device cannot be extracted from this document. The document describes the performance testing of a physical product (surgical gowns) against established standards for physical properties and safety.

However, I can extract the acceptance criteria and performance for the surgical gown itself as presented in the document.

Detailed Breakdown based on the provided document:

The product in question is a physical medical device (surgical gown), not an AI/ML powered device. As such, the study design and acceptance criteria relate to the physical properties, safety, and performance of the gown, not to AI model performance, human reader improvement, or ground truth establishment in the context of AI/ML.

Here's an attempt to answer your questions based on the available information in the provided document, acknowledging the mismatch with a typical AI/ML device request:

1. A table of acceptance criteria and the reported device performance

Test Item	Acceptance Criteria	Reported Device Performance
Sterilization Validation	Sterility Assurance Level: 10^-6	Pass
Shelf-Life Validation	Bioburden test: ISO 11737-1 ('Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products' Sterility test: No microbial growth Seal Strength Test (Blister): Maximum seal strength (N/15mm) ->>1.2 Dye Penetration test: No leakage	Pass
Acute systemic toxicity	Adverse no effects occurring at any time within 72h after single, multiple or continuous exposures of a test sample for 24h.	Pass
Sensitization & Irritation Tests	Sensitization test: The observations are scored between 0 (no visible change) to 3 (intense erythema and swelling). More than grade 0 indicates sensitization. Irritation tests: The test result obtained is a score between 0 and 8 calculated from the various observations, considered as negligible (0-0.4), slight (0.5-1.9), moderate (2-4.9), or severe (5-8).	Pass
Water Resistance: Impact Penetration	Visual Penetration: None seen Amount of Penetration (g) : ≤ 1.0 g	Pass
Water Resistance: Hydrostatic Pressure	Pressure: ≥ 50 cm (Specifically for Level 3 Surgical Gowns based on ANSI/AAMI PB70:2012)	Pass
Tear Resistance	No acceptance criteria currently exist for this test.	Pass
Basis Weight	Test articles should be weighed, and the basis weight should be calculated as the mass divided by the area. all should weigh the same.	Pass
Sterilant Gas Residue Analysis	Maximum levels of sterilant residuals: ETO < 25ppm/device, ECH < 25ppm/device (ISO 10993-7)	Pass
Tensile Testing	No acceptance criteria currently exist for this test.	Pass
Flammability	Class Plain Surface Textile Fabric: Burn time ≥3.5 seconds	Pass
Seam Strength test	No acceptance criteria currently exist for this test.	Pass

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample sizes (number of gowns) used for each test. It states "The following tests were performed on the subject device and the test results support that the subject device met the requirement for each test."
Data Provenance: The document does not specify the country of origin of the test data. It indicates the manufacturer is "Unico Global VN Co., Ltd." in the "Republic of Korea" (though the contact person is in Irvine, California). The testing is non-clinical, likely conducted in a lab setting, not on patient data. The tests are prospective in the sense that they are conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is not an AI/ML device requiring expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective measurements against established engineering and safety standards (e.g., amount of water penetration, sterilant residue concentration).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device performance test. The results are typically numerical measurements or pass/fail determinations based on predefined criteria, not expert adjudication of qualitative findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This is not an AI/ML device where human readers interact with AI. The regulatory submission focuses on demonstrating substantial equivalence of the surgical gown's physical properties and safety to a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not an AI/ML device. The tests performed are for the physical product's performance independently.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements against internationally recognized performance standards (e.g., AATCC Test Method 42, AATCC Test Method 127, ISO 11135-1, ASTM D5587, ISO 10993-11, etc.). It's based on the physical and chemical properties of the material, not clinical outcomes or expert consensus on observations.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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December 10, 2021

Unicoglobal, Inc. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, California 92620

Re: K203539

Trade/Device Name: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: October 26, 2021 Received: December 1, 2021

Dear Priscilla Chung:

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.

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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 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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K203539

Device Name

Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

Indications for Use (Describe)

The Unico Global Level 3 Surgical Gowns meets the requirements of ANSV/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile. Non-sterile gowns are to be sold to re-packager/relabeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K203539)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Dec 7, 2021

1. 510K Applicant / Submitter:

Unicoglobal, Inc. #904. Woolim Pangyo W-City 9-22, Pangyo-Ro 255bion-Gil Bundang-gu, Seongnam City Gyeonggido, 13486 Republic of Korea

2. Submission Contact Person

LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

. Proprietary Name: Unico Global level 3 Surgical Gown (Film-reinforced SMS) Unico Global Level 3 Surgical Gown (PP+PE)
Common Name: Surgical Gown .
Classification: Class II (21 CFR 878.4040) ●
Product Code: FYA .

4. Predicate Device

Medline Level 2 Surgical Gown (Eclipse Non-Reinforced) Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced) Medline Level 3 Surgical Gown (Sirus Non-Reinforced) Medline Level 3 Surgical Gown (Sirus Fabric Reinforced) Medline Level 3 Surgical Gown (Aurora Non -Reinforced & Aurora Fabric Rein

(K190950) by Medline Industries, Inc.

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5. Description:

The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.

6. Indications for Use

The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) 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 Unico Global Level 3 Surgical Gowns meets the respective level requirements of ANSI/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile or nonsterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 11135-1.

7. Comparison of Technological characteristics:

The predicate device is as follows:

K 190950 by Medline Industries, Inc.

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8. Comparison Chart

DeviceCharacteristic	Subject Device	Predicate Device	Remark
Device Name	Unico Global level 3 SurgicalGown (Film-reinforced SMS)Unico Global Level 3 SurgicalGown (PP+PE)	Medline Level 2 Surgical Gown(Eclipse Non-Reinforced)Medline Level 3 Surgical Gown(Eclipse Fabric Reinforced)Medline Level 3 Surgical Gown (SirusNon-Reinforced)Medline Level 3 Surgical Gown (SirusFabric Reinforced)Medline Level 3 Surgical Gown (AuroraNon - Reinforced & Aurora FabricReinforced	-
510K #	K203539	K190950	-
Manufacturer	Unico Global VN Co., Ltd.	Medline Industries, Inc.	-
Product Code	FYA	FYA	Same
Indications forUse	The Unico Global Level 3Surgical Gown (Film-reinforcedSMS) and Unico Global Level 3Surgical Gown (PP+PE) aresterile, single use surgical apparelintended to be worn by healthcareprofessionals to help protect boththe patient and the healthcareworker from the transfer ofmicroorganisms, body fluids andparticulate matter.The Unico Global Level 3Surgical Gowns meets therespective level requirements ofANSI/AAMI PB70:2012 level 3liquid barrier performance andclassification of protectiveapparel and drapes intended foruse in health care facilities.The Unico Global Level 3Surgical Gown (Film-reinforcedSMS) and Unico Global Level 3Surgical Gown (PP+PE) aresingle use, disposable medicaldevices; provided sterile or non-sterile. Non-sterile gowns are tobe sold to re-packager/re-labelerestablishments for ethylene oxide(EtO) sterilization according toISO 11135-1 prior to marketing tothe end users and sterile surgicalgowns are to be sold directly tousers after EtO sterilizationvalidation to ISO 11135-1.	The Medline Level 2 Surgical Gown(Eclipse Non Reinforced) and MedlineLevel 3 Surgical Gown (Eclipse FabricReinforced),Medline Level 3 Surgical Gown (SirusNon-Reinforced & Sirus FabricReinforced), Medline Level 3 SurgicalGown (Aurora Non- Reinforced &Aurora Fabric Reinforced) are sterile,single use surgical apparel intended tobe worn by healthcare professionals tohelp protect both the patient and thehealthcare worker from the transfer ofmicroorganisms, body fluids, andparticulate matter.The Medline Level 2 Surgical Gownand the Medline Level 3 SurgicalGowns meet the respective levelrequirements of ANSI/AAMIPB70:2012 Liquid barrier performanceand classification of protective appareland drapes intended for use inhealthcare facilities.The Medline Level 2 Surgical Gownand the Medline Level 3 SurgicalGowns have been validated using anethylene oxide (EtO) sterilizationprocess. The Medline Level 2 SurgicalGown and the Medline Level 3 SurgicalGowns are also sold asbulk single-use, non-sterile, torepackager/relabeler establishments forfurther packaging and sterilization usingthe validated EtO sterilization methodaccording to ISO 11135-1 prior to beingprovided to the end user.	Same
Color	Blue	Blue	Same
Design Feature	Film-reinforcedSMSVelcro hookand loop withneck straps atneckSingle useBelt StrapsKnit CuffsTransfer TabSet-in Sleeves	PP+PENeck strapsSingle useBelt strapsKnit cuffsSet-in Sleeves	Available in Fabric Reinforced and NonReinforcedVelco hook and loop for neck closureSingle UseBelt StrapsKnit CuffsTransfer TabRaglan or Set-in/Standard Sleeves	Similar
Size	Medium to XX-Large		Small to XXXX-Large	Similar
Materials	Film (PE) Reinforced Nonwoven SMSPolypropylene/Polyethylene		Nonwoven SMSPolypropylene/Polyolefin	Different
PerformanceSpecifications	Level 3 PB70 Barrier Protection		Level 2 PB70 Barrier ProtectionLevel 3 PB70 Barrier Protection	Same
Prescriptionvs. OTC	OTC		OTC	Same
ContactDurations	Surface, Intact, < 24 hours		Surface, Intact, < 24 hours	Same
Sterile vsNon-Sterile	Non-sterileSterile		Sterile	Similar
Single Use vs.Reusable	Single Use		Single Use	Same
Biocompatibility	Under the test conditions, thesubject device was shown to benon-systemic toxic, non-irritatingand non-sensitizing per ISO10993-11 & ISO 10993-10		Under the test conditions, the subjectdevice was shown to be non-cytotoxic,non-irritating and non-sensitizing perISO 10993-5 & ISO 10993-10.	Similar
Flammability	Meets requirements of FlameResistant CPSC 1610 Class 1		Meets requirements of Flame ResistantCPSC 1610 Class 1	Same
SterilizationMethod	Ethylene Oxide (EtO)		Ethylene Oxide (EtO)	Same

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The subject device and the predicate device have the same indications for Use and has similar technological characteristics.

The major differences are materials and design. The predicate device uses a traditional nonwoven SMS (3-layer) fabric, whereas the subject device uses a traditional non-woven SMS (3-layers) plus an extra film layer. The subject device has an additional material model which was made with PP+PE which is spunbond (PP) fabric with a PE Film-reinforced layer. For the design of the gowns, both the subject device and the predicate device have a Velcro hook and loop at neck (only for the subject SMS model), belt straps, knitted cuff, transfer tab, and setin sleeve features.

The major design difference is that the subject SMS gowns has an additional neck strap at the neck in addition to the Velcro hook and loop. The subject PP+PE gowns have a neck strap only.

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Other than this, both the devices share the same design features.

We have performed the biocompatibility and performance tests on the subject device and based on the test results we determine that these differences do not affect the safety and effectiveness of the device.

9. Summary of Non-Clinic Performance Tests

The following tests were performed on the subject device and the test results support that the subject device met the requirement for each test. Especially the performance test results support that the subject device satisfied the requirement of level 3 surgical gown.

Test Item	Test Standard	Acceptance Criteria	Results
Sterilization Validation	ISO 11135-1:2014	Sterility Assurance Level: 10-6	Pass
Shelf-Life Validation	ASTM F1980, ASTM F88, ASTMF1929, ISO 10993-7, ISO 11737-2	Bioburden test: ISO 11737-1'Sterilization of medical devices– Microbiological methods – Part1: Determination of a populationof microorganisms on products' Sterility test: No microbialgrowth Seal Strength Test (Blister):Maximum seal strength(N/15mm) ->>1.2 Dye Penetration test: No leakage	Pass
Acute systemictoxicity	ISO 10993-11	Adverse no effects occurring at anytime within 72h after single, multipleor continuous exposures of a testsample for 24h.	Pass
Sensitization &Irritation Tests	ISO 10993-10	Sensitization test: Theobservations are scored between 0(no visible change) to 3 (intenseerythema and swelling). Morethan grade 0 indicatessensitization. Irritation tests: The test resultobtained is a score between 0 and8 calculated from the variousobservations, considered asnegligible (0-0.4), slight (0.5-1.9),moderate (2-4.9), or severe (5-8).	Pass
Water Resistance:Impact Penetration	AATCC Test Method 42 and is inaccordance with ANSI/AAMI PB70	Visual Penetration: None seenAmount of Penetration (g) : ≤ 1.0 g	Pass
Water Resistance:Hydrostatic Pressure	AATCC Test Method 127:2017,ANSI/AAMI PB70:2012, and ISO811:2018	Pressure: ≥ 50 cm	Pass
Tear Resistance	ASTM D5587	No acceptance criteria currently existfor this test.	Pass
Basis Weight	ASTM D3776	Test articles should be weighed, andthe basis weight should be calculatedas the mass divided by the area. allshould weigh the same.	Pass
Sterilant Gas Residue Analysis	ANSI/AAMI/ISO 10993-7	Maximum levels of sterilant residuals:ETO < 25ppm/device, ECH < 25ppm/device (ISO 10993-7)	Pass
Tensile Testing	SFDA (21 CFR Parts 58, 210, 211, and 820) Regulations	No acceptance criteria currently exist for this test.	Pass
Flammability	16 CFR part 1610	Class Plain Surface Textile Fabric:Burn time ≥3.5 seconds	Pass
Seam Strength test	ASTM D1683/D1683M	No acceptance criteria currently exist for this test.	Pass

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10. Conclusions:

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(K) submission K203539, the Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K190950.

Regulation Number and Section

§ 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.