(150 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device's intended use is to protect from transfer of microorganisms and body fluids, not to treat or diagnose a disease or condition.
No
A surgical face mask is a protective barrier device, not a device used to diagnose medical conditions. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose piece) and the performance studies are based on physical testing of these components, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material, and for reducing exposure to blood and body fluids. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, test strips, or any components used to analyze biological samples.
- Lack of IVD Characteristics: IVDs are designed to diagnose diseases or conditions by examining samples like blood, urine, or tissue. This device does not perform any such analysis.
- Testing Performed: The performance studies focus on the physical properties of the mask (fluid resistance, filtration efficiency, breathability, flammability), which are relevant to its function as a barrier, not as a diagnostic tool.
In summary, the Private Stock Labs Surgical Face Mask is a medical device intended for personal protection and infection control, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Fluid Resistance Performance ASTM F1862: This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. Acceptance Criteria: 29 out of 32 pass at 120mmHg. Result: Lot 1: 32 out of 32 pass at 120mmHg; Lot 2: 32 out of 32 pass at 120mmHg; Lot 3: 32 out of 32 pass at 120mmHg.
Particulate Filtration Efficiency ASTM F2299: The PFE test is performed to evaluate ≥ 98% the non-viable particle filtration efficiency of the test article. Acceptance Criteria: ≥ 98%. Result: 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: The BFE test is performed to determine the bacterial filtration efficiency of test articles. Acceptance Criteria: ≥98%. Result: Lot 1: 99.9%; Lot 2: 99.9%; Lot 3: 99.9%.
Differential Pressure (Delta-P) MIL-M-36954C: The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. Acceptance Criteria:
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K211425
Device Name
Private Stock Labs Surgical Face Mask
Indications for Use (Describe)
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.
| 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 Alexiades
Mdi 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:
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
4
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:
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 nonsterile.
| 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 CFR | ||
| 878.4040) | Class II Device, FXX (21 CFR | ||
| 878.4040) | Same | ||
| Intended use | 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. | The Surgical Face Masks are intended to | ||
| be worn to protect both the patient and | |||
| healthcare personnel from transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. These face masks | |||
| are 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. | Same | ||
| Mask style | Flat Pleated | Flat Pleated | Same |
| Design | Ear loop | Ear loop | Same |
| Layers | Three | Three | Same |
| Color | Green outside; white inside | Yellow | Similar |
| Note 1 | |||
| Target | |||
| population | Adults | Adults | Same |
| Dimension | |||
| (Length) | $175mm\pm5mm$ | $17.5cm\pm0.2cm$ | Similar |
| Note 2 | |||
| Dimension | |||
| (Width) | $95mm\pm5mm$ | $9.5cm\pm0.2cm$ | Similar |
| Note 2 | |||
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical | |||
| site | Nose and mouth | Nose and mouth | Same |
| Environment | |||
| of use | OTC | OTC | Same |
| Material | |||
| Outer facing | |||
| layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing | |||
| layer | 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. 62570-50-7 | ||
| Disperse Blue 360 - CAS No. 17095-24-8 | |||
| Disperse Red 60 - CAS No. 17418-58-5 | |||
| Disperse Yellow 54 - Cas No. 7576-65-0 | Unknown | Similar | |
| Note 1 | |||
| ASTM F2100 | |||
| Level | Level 2 | Level 2 | Same |
| Biocompatibility (limited contact ( |