K050689 · China Surgical Dressings Center Co., Ltd. · FXX · Oct 26, 2005 · General, Plastic Surgery
Device Facts
Record ID
K050689
Device Name
SURGICAL FACE MASK
Applicant
China Surgical Dressings Center Co., Ltd.
Product Code
FXX · General, Plastic Surgery
Decision Date
Oct 26, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
Surgical Face Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. The intended use is not only for surgical room but also for isolation, dental or medical procedure use. This products is intended for use in infection control practices to minimize contamination caused by exhaled and inhaled microorganisms, body fluids, and particulate material. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
Device Story
Surgical Face Mask; 3-ply non-woven material; flat, pleated design; tie-on or elastic ear-loop attachment; malleable plastic-coated wire nose piece. Covers nose and mouth. Used in operating rooms, isolation, dental, or medical procedures. Provides physical barrier against fluids, particulate materials, and microorganisms. Protects wearer from blood/body fluid exposure; minimizes contamination from exhaled/inhaled particles. Performance: 95% Bacteria Filtration Efficiency (BFE) at 3.0 µm.
Clinical Evidence
Bench testing only. Nelson report cited for Bacteria Filtration Efficiency (BFE) of 95% at 3.0 µm particle size.
Technological Characteristics
3-ply non-woven material; inner/outer cover webs with middle filter web; tie-on or elastic ear-loop; malleable plastic-coated wire nose piece. BFE 95% at 3.0 µm.
Indications for Use
Indicated for operating room personnel during surgical procedures to protect patients and personnel from transfer of microorganisms, body fluids, and particulate materials.
Regulatory Classification
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.
Special Controls
*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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## 8. PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR SURGICAL 05068 MASK 001 2 5 2005
8.1 Submitter's name: China Surgical Dressings Center Co., Ltd.
8.2 Address: No. 21, Lane 424, Sec. 6, Chang-Nan Road, Changhwa City Taiwan, Republic of China.
- 8.3 Phone No: 886-4-7385026
- 8.4 Fax No: 886-4-7384720
- 8.5 Contact person: Mr. Michael F. L. Chang CONTACT ADDRESS: 4F, No. 232, Jen Ai Road Sec. 4, Taipei City, Taiwan Republic of
China
TEL: 886-2-2703-3798 FAX: 886-2-2704-3212 E-mail: info@csdmedic.com.tw
- 8,6 Date prepare: December,29, 2004
8.7 Trade name/proprietary name: Surgical Face Mask
- 8.8 Common name/usual name: Face Mask
8.9 Classification name: Mask, surgical
| TRADE NAME | COMMON NAME | CLASSIFICATION NAME |
|--------------------|-------------|---------------------|
| Surgical Face Mask | Face Mask | Mask, surgical |
#### Legally market device equivalence: 8.10
3M 1818 Tie-on Surgical Mask and 3M 1818FS Tie-on Surgical Mask with Face Shield 510k number: K940707 Manufacturer: 3 M
Crosstex ® Isolite® Earloop Face Masks K012602
#### 8.11 Intended use:
Surgical Face Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. The intended use is not only for surgical room but also for isolation, dental or medical procedure use. This products is intended for use in infection control practices to minimize contamination caused by
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for surgical room but also for isolation, dental or medical procedure use. This products is intended for use in infection control practices to minimize contamination caused by exhaled and inhaled microorganisms, body fluids, and particulate material. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.
### 8.12 Indication for use (SEE APPENDIX IV)
surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
#### 8.13 Device description
The Surgical Face Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of 3-ply Non-Woven material; inner and outer cover web with middle different filter web sandwiched in between. It covers the nose and mouth of the wearer, and is held in place by tie string or elastic ear loop and a malleable plastic coated wire nose piece. For protection against airborne particles and splatters of blood and saliva…etc
According to Nelson report for the BFE (Bacteria Filtration Efficiency) up to 95% at 3.0 µm particle size.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
OCT 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
China Surgical Dressings Center Co., Ltd. C/O Mr. Michael F. L. Chang President China Surgical Dressings Center Product 4 F. 232 JEN AI Rd., Sec. 4 Taipei, Taiwan REPUBLIC OF CHINA
Re: K050689
Trade/Device Name: SURGICAL FACE MASK Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: October 17, 2005 Received: October 21, 2005
Dear Mr. Chang:
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 approvisions of the Act. The general controls provisions of the Act include eonerols province annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it may be ode of Federal Regulations, Title 21, Parts 800 to 898. In your device ear to four her announcements concerning your device in the Ecderal Register.
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#### Page 2 - Mr. Chang
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. or the rot of any 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 and insting (2 = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as 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) Fine reter 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 (240) 276-0115. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may oblain other general information on your responsibilities under the Act from the maj count 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/industry/support/indcx.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): 050689
Device Name: Surgical Face Mask
Indications For Use:
Surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to mended to be vern by
the operating management procedure to procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ V (21 CFF) 801 Subpart C)
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGEIF NEEDED)
Concurrence of CDRH , office of Device Evaluation(ODF)
Page 1 of 1
32
C. Ruiz. C.
riston Sign-Off) Prision Sign-Off)
Mision of Anesthesiology, General Hospital, Antalon Control, Dental Device
510(k) Number: K050689
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