The Private Stock Labs Surgical Face Mask is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. Private Stock Labs Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Device Description

PRIVATE STOCK LABS Surgical Face Mask is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Surgical Face Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.

AI/ML Overview

This document describes the non-clinical testing performed for the Private Stock Labs Surgical Face Mask (K211425) to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Result for 3 Lots)
Fluid Resistance ASTM F1862	Evaluate Personal Protective Equipment against fluid penetration, simulating arterial spray.	29 out of 32 pass at 120mmHg	Lot 1: 32 out of 32 pass at 120mmHgLot 2: 32 out of 32 pass at 120mmHgLot 3: 32 out of 32 pass at 120mmHg
Particulate Filtration Efficiency ASTM F2299	Evaluate the non-viable particle filtration efficiency.	≥ 98%	Lot 1: 99.9% (32 out of 32 pass)Lot 2: 99.9% (32 out of 32 pass)Lot 3: 99.9% (32 out of 32 pass)
Bacterial Filtration Efficiency ASTM F2101	Determine the bacterial filtration efficiency.	≥98%	Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9%
Differential Pressure (Delta-P) MIL-M-36954C	Ensure the pressure drop is not too great for user breathing.	< 6.0mmH2O/cm²	Lot 1: 5.75 mmH2O/cm²Lot 2: 6.0 mmH2O/cm²Lot 3: 3.94 mmH2O/cm²
Flammability Class 16CFR 1610	Ensure the device does not ignite when exposed to flame.	Class 1	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: For each test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability Class), 3 non-consecutive lots were tested. Each lot contained 32 samples.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes "non-clinical tests" performed to demonstrate compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This document describes non-clinical performance testing of a physical medical device (surgical face mask) against established industry standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16CFR 1610). The "ground truth" for these tests are the objective measurements specified by the standards, not expert consensus on qualitative data. Therefore, the concept of "experts establishing ground truth" as it applies to subjective interpretations (like in imaging studies) is not applicable here. The testing would have been performed by laboratory technicians following validated protocols.

4. Adjudication Method for the Test Set:

Not applicable. The tests involve objective measurements against predefined criteria/standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a surgical face mask, not an AI or imaging diagnostic device that would involve human readers or comparative effectiveness studies with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The ground truth for these tests is established by objective measurements and adherence to specified performance standards outlined in the referenced ASTM, MIL, and CFR documents. For example, for Bacterial Filtration Efficiency, the "ground truth" is a measured percentage of bacteria filtered, compared against a numerical threshold (≥98%).

8. Sample Size for the Training Set:

Not applicable. This document describes the non-clinical performance testing of a finished medical device according to established standards. There is no "training set" in the context of machine learning or AI algorithms for this type of device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned or implied for this device's testing.

Summary

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October 4, 2021

J.K. Private Stock Inc. % Nickita Alexiades Regulatory Affairs Consultant/Engineer mdi Consultants, Inc. 55 Northern Boulevard. Suite 200 Great Neck, New York 11021

Re: K211425

Trade/Device Name: Private Stock Labs Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 26, 2021 Received: August 31, 2021

Dear Nickita Alexiades:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

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) K211425

Device Name

Private Stock Labs Surgical Face Mask

Indications for Use (Describe)

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)	☒

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510(k) SUMMARY

. 1. Submitter's Identification:

Applicant:Address:	J.K. PRIVATE STOCK INC.68-05 Fresh Meadow Lane, Fresh Meadows, NY 11365, USA
Contact Person:	Jonathan Koon
Tel:	(718)-886-3163
Email:	jonathan.koon@gmail.com
Date Summary Prepared:	January 13, 2020
Official Correspondent:	Mr. Nickita AlexiadesMdi Consultants, Inc.
Address:	55 Northern Blvd. Suite 200, Great Neck, NY, United States
Tel:	201-220-2152
Email:	nickita@mdiconsultants.com

2. Name of the Device:

Proprietary Name:	Private Stock Labs Surgical Face Mask
Classification Name:	Mask, Surgical
Common Name:	Surgical Mask
Regulatory Class:	II
Product Code:	FXX
Regulation Name:	Surgical Apparel
Regulation Number:	878.4040
Review Panel:	General Hospital

3. Information for the 510(k) Cleared Device (Predicate Device):

Surgical Face Mask, K182515

Surgical Face Mask

Wuhan Dymex Healthcare Co., Ltd.

No reference devices were used in this submission.

4. Device_Description:

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loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.

5. Indications for Use:

Device	Proposed device	Predicate device	Comparison
510(k) Holder	J.K. PRIVATE STOCK INC.	WUHAN DYMEX HEALTHCARE CO., LTD	--
510(k) Number		K182515	--
Name	Private Stock Labs Surgical Face Mask	Surgical Face Mask	--
Model	PSL-SA3		--
Classification	Class II Device, FXX (21 CFR878.4040)	Class II Device, FXX (21 CFR878.4040)	Same
Intended use	The Private Stock Labs Surgical FaceMask is intended to be worn to protectboth the patient and health carepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. Private Stock LabsSurgical Face Mask is intended for usein infection control practices to reducethe potential exposure to blood and bodyfluids. This is a single use, disposabledevice(s), provided non-sterile.	The Surgical Face Masks are intended tobe worn to protect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids. Thisis a single use, disposable device(s),provided non-sterile.	Same
Mask style	Flat Pleated	Flat Pleated	Same
Design	Ear loop	Ear loop	Same
Layers	Three	Three	Same
Color	Green outside; white inside	Yellow	SimilarNote 1
Targetpopulation	Adults	Adults	Same
Dimension(Length)	$175mm\pm5mm$	$17.5cm\pm0.2cm$	SimilarNote 2
Dimension(Width)	$95mm\pm5mm$	$9.5cm\pm0.2cm$	SimilarNote 2
Sterility	Non-sterile	Non-sterile	Same
Use	Single use, disposable	Single use, disposable	Same
Anatomicalsite	Nose and mouth	Nose and mouth	Same
Environmentof use	OTC	OTC	Same
Material
Outer facinglayer	Spunbond polypropylene	Spunbond polypropylene	Same
Middle layer	Melt blown polypropylene filter	Melt blown polypropylene filter	Same
Inner facinglayer	Spunbond polypropylene	Spunbond polypropylene	Same
Ear loops	Spandex	Spandex	Same
Nose piece	Malleable polyethylene wire	Malleable polyethylene wire	Same
Colorants	Disperse Blue 359 - CAS No. 62570-50-7Disperse Blue 360 - CAS No. 17095-24-8Disperse Red 60 - CAS No. 17418-58-5Disperse Yellow 54 - Cas No. 7576-65-0	Unknown	SimilarNote 1
ASTM F2100Level	Level 2	Level 2	Same
	Biocompatibility (limited contact (<24h) surface devices on intact skin)
Cytotoxicity	Under the conditions of the study, theproposed device extract was determinedto be non-cytotoxic.	Under the conditions of the study, thepredicate device extract was determinedto be non-cytotoxic.	Same
Irritation	Under the conditions of the study, theproposed device non-polar and polarextracts were determined to be non-irritating.	Under the conditions of the study, thepredicate device non-polar and polarextracts were determined to be non-irritating.	Same
Sensitization	Under the conditions of the study, theproposed device non-polar and polarextracts were determined to be non-sensitizing.	Under the conditions of the study, thepredicate device non-polar and polarextracts were determined to be non-sensitizing.	Same
	Differences between Subject device and Predicate Device:
Note 1:

Technological Characteristics Comparison: 6.

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Biocompatibility evaluation has been performed on the finished device which includes all construction materials and color additives.

Note 2:

The tolerance of dimension are a little different between proposed device and predicate device.

7.Summarv of Non-Clinical Tests :

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The following testing was conducted to demonstrate that the subject device (3 nonconsecutive lots with each lot containing 32 samples) met the acceptance criteria and specification of the standard shown below.

Test Methodology	Purpose	Acceptance Criteria	Result
Fluid ResistancePerformanceASTM F1862	This test isperformed toevaluate PersonalProtectiveEquipment againstfluid penetration.An arterial spray issimulated to testthe PPE.	29 out of 32 pass at120mmHg	Lot 1: 32 out of 32 passat 120mmHgLot 2: 32 out of 32 passat 120mmHgLot 3: 32 out of 32 passat 120mmHg
Particulate FiltrationEfficiencyASTM F2299	The PFE test isperformed to evaluate $≥ 98%$the non-viable particlefiltration efficiency ofthe test article.	$≥ 98%$	Lot 1: 99.9%32 out of 32 passLot 2: 99.9%32 out of 32 passLot 3: 99.9%32 out of 32 pass
Bacterial FiltrationEfficiencyASTM F2101	The BFE test isperformed todetermine the bacterialfiltration efficiency oftest articles.	$≥98%$	Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9%
Differential Pressure(Delta-P)MIL-M-36954C	The purpose of thistest is to ensure thedrop in pressure is nottoo great so the usermay breathe throughthe subject device.	< 6.0mmH2O/cm2	Lot 1: 5.75 mmH2O/cm²Lot 2: .0 mmH2O/cm²Lot 3: 3.94 mmH2O/cm²
Flammability class16CFR 1610	The purpose of thistest is to ensure thesubject device doesnot ignite whenexposed to flame.	Class 1	Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1

8.Discussion of Clinical Tests Performed:

No clinical study is included in this submission.

9.Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Wuhan Dymex Healthcare Co., Ltd. Disposable Surgical Face Mask cleared under K182515.

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.