(214 days)
Not Found
No
The description focuses on the physical materials and performance testing of a facemask/shield, with no mention of AI or ML technologies.
No
The device, a surgical facemask/shield, is intended to protect against the transfer of microorganisms, body fluids, and particulate matter. It is a barrier device for protection, not designed to treat or cure a disease or condition.
No
The device, a facemask/shield, is designed to protect from transfer of microorganisms and body fluids, not to diagnose medical conditions.
No
The device description clearly describes physical components (pleated 3-ply masks, polypropylene filter material, plastic shield) and performance testing related to physical properties (filtration efficiency, pressure differential, flammability, skin irritation). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical barrier (mask with optional shield) made of materials designed for filtration and protection. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies focus on the physical properties and protective capabilities of the mask (filtration efficiency, pressure differential, flammability, skin irritation). These are not diagnostic metrics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This facemask/shield does not perform such a function.
N/A
Intended Use / Indications for Use
Medical facemask / shield are intended to be used 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 matter.
Product codes
FXX
Device Description
These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization.
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
operating room personnel / during surgical procedures
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)
non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
JUN 1 0 2003
Winner
17415-1 Sia Pirk Circle it > me. > : http:// 92614
රික්රමය විකාශ ප්රධාන පිහිටා පිහිටි පිහිටි පිහිටි විසින් පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි ප
mer Modical | SA. Inc.
Tel: 949-161-5339 Firm 9 Fr - 35 L9007
510K SUMMARY
This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510K number is: K023755
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- Submitter's Identification:
Winner Industries Co., LTD Winner Industrial Park,Bulong RD., Longhua, Shenzhen Shenzhen China 518109 Telephone: 86-755-28138888 Facsimile: 86-755-28134588
- Submitter's Identification:
U.S. Agent: Winner Medical USA, Inc. 17815 Sky Park Circle, Suite A Irvine, California 92614 Telephone: 800-996--9222 Facsimile: 949-261-9007
Contact Person: Ming Xie, Vice President
Date of Summary: 11-3-02
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- Device Name:
Winner Ear Loop Procedure Mask, Blue, Pink, White & Green Winner Tie-On Surgical Mask, Blue, Pink, White & Green Winner Ear Loop Procedure Mask with Shield, Blue, Pink, White & Green Winner Tie-On Surgical Mask with Shield, Blue, Pink, White & Green
- Device Name:
-
- Classification Name: Mask, Surgical
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- Predicate Device:
1
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- Intended Use: Medical facemask / shield are intended to be used 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 matter.
-
- Device Description/ Comparison:
These masks are pleated 3-ply masks with an inner and outer layer that sandwich a polypropylene filter material. On some masks a plastic shield with a non-fog coating is incorporated. The masks are identical to the predicate devices in design, materials used and performance in non-clinical testing. This testing included bacterial filtration efficiency (BFE), pressure differential (Delta P), flammability, ISO skin irritation and sensitization. This information has been included with this submission.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2003
Winner Industries (Shenzhen) Company Limited C/O Mr. Ming Xie Winner Medical USA, Incorporated 17815 Sky Park Circle, Suite A Irvine, California 92614
Re: K023755
Trade/Device Name: Winner Ear Loop Procedure Mask, Tie-On Surgical Mask & Ear-Loop White, Green, Blue, Pink with and without Face Shield Regulation Number: 878.4040 Regulation Name: Surgical Mask Regulatory Class: II Product Code: FXX Dated: May 13, 2003 Received: May 14, 2003
Dear Mr. Xie:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Xie
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susa Purser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510k Number (if Known): K023755
Device Name: Winner Medical Facemasks (various colors, with and without shields)
Indications for Use:
Winner Medical facemask / shield are intended to be used 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 matter.
Concurrence of CFRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use:
Olin S. Lir
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K023755