DS N95 SURGICAL MASKS AND FLAT SURGICAL
Device Facts
| Record ID | K090131 |
|---|---|
| Device Name | DS N95 SURGICAL MASKS AND FLAT SURGICAL |
| Applicant | Shanghai Dasheng Health Products |
| Product Code | MSH · General, Plastic Surgery |
| Decision Date | Apr 27, 2009 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Device Story
Device consists of N95 surgical respirators (DTC3M-1, DTC3B) and flat pleated surgical masks. N95 models utilize multi-layer polypropylene/melt-blown filter media, nose wires, and elastic head straps to provide respiratory protection. Flat masks utilize 3-ply spunbonded polypropylene with melt-blown filter layers, ear loops, and malleable nose wires; some variants include anti-fog strips or splash visors. Used in clinical settings (OR, dental, isolation) by healthcare personnel. Masks act as physical barriers to microorganisms, fluids, and particulates. Single-use, non-sterile.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including NIOSH exhalation/inhalation resistance (84.180), NIOSH NaCl filtration efficiency (84.181), flammability (16 CFR 1610 Class I), and biocompatibility (ISO 10993).
Technological Characteristics
Materials: polypropylene spunbond, melt-blown PP micro-fiber, Terylene, natural rubber/woven elastic, EVA/sponge foam nosepieces. Design: N95 molded cup or flat pleated. Energy: None (passive). Connectivity: None. Sterilization: Non-sterile. Standards: NIOSH TC-84A-4336, TC-84A-4331, ISO 10993, 16 CFR 1610.
Indications for Use
Indicated for operating room personnel and health care workers to protect patients and staff from transfer of microorganisms, blood, body fluids, and airborne particulates.
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.
Predicate Devices
- Pleated plus 1050 and 1050S (K041855)
- APR Type N95 model 2735 (K960778)
- Surgical face masks white, yellow, pink, blue and green (K022256)
Submission Summary (Full Text)
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Shanghai Dasheng Health Products Manufacture Co.,Ltd
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai Tel: 86-21-57783126 Fax: 86-57784148
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# 510(k) Summary
APR 2 7 2009
This summary of 510K safety and effectiveness information is being submitted in accrodance with the requirements of 21 CFR 807.92
The assigned 510K number is KO9013
1. Submitter's Identification:
Shanghai Dasheng Health Products Manfuacture Co.,Ltd No.228 Shihui Road, Zhongshan street, Songjiang District,
Shanghai, P.R.China
Contact:
Maggie Zhong Tel:+86-21-33907930 Fax:+86-21-33907932 Mail:
Date of Summary: Jan 11th, 2009
- યં Device Name:
DS N95 Surgical Masks and flat surgical masks
- 3. Classification Name: Surgical N95 Mask and flat surgical mask
- Device Description 4..
The DS DTC3M-1 N95 surgical mask is constructed from a polypropylene spunbond used in the outer layer. The non-woven PP micro is the filter media and the Terylene is layered as the inner. The head strap is made of natural rubber(for double head straps) which is stapled to the mask. The inside nosepiece is a soft sponge foam.
The DS DTC3B N95 surgical mask is constructed from a polypropylene spunbond used in the outer cover, a polypropylene spunbond used in the inner cover. The non-woven PP micro fiber and polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of woven elastic strap(for single headband) which is circule to the mask. The inside nosepiece is a EVA micro-aperture foam.
The flat surgical masks (colors: blue, green, pink, white, yellow, orange) are flat pleated by 3-ply masks with outer layer and inner layers (spunbonded polypropylene) that sanwich a meltbown non-woven PP micro fibre filter material Ear-loops are made of spandex belt for free elastic loops. The nose piece for all DS Face Masks is malleable wire. Fog free masks have an anti-fog strip. Masks with splash visors have anti-fog treated plastic shield attached to masks,All of the material used in the construction of the DS Surgical Masks are being used in currently marketed devices (see predicate information).
All items are no - sterilized and only for single use.
- Intended Use:
DS N95 surgical masks and flat surgical mask are intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use procedure mask, isolation mask or dental face mask
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# Shanghai Dasheng Health Products Manufacture Co.,Ltd K09013|
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai Tel: 86-21-57783126 Fax: 86-57784148
Page 2 of 3
## 6. Comparison to Predicate Devices
DS N95 surgical masks DTC3M-1. DTC3B and flat surgical masks color pink, blue, white, green, yellow, orange are substantially equivalent is safety and effectiveness to the predicate device.
Aearo Company- K041855 Pleated plus 1050 and 1050S
Gerson Isolair Compay-K960778 APR Type N95 model 2735
Tucker & Associates company-K022256 Surgical face masks white, yellow, pink, blue and green For reference: FXX, 878, 4040. Class II
| Manufacturer | Shanghai Dasheng Health Products<br>Manufacture Co.,Ltd | Aearo Company<br>Predicate device-for reference |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | DTC3B N95 Surgical Mask<br>(New device) | Pleated plus 1050 and 1050S |
| 510K Number | | K041855 |
| Product code | MSH, 878.4040 | SAME |
| Device<br>Description | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(white polypropylene spundbond, Non-woven<br>PP Micro fiber meltblown, polypropylene,<br>polypropylene)<br>3. Plastic nose wire<br>4. White elastic headband<br>5. Dimension<br>15.5" circumference<br>6. Flat pleated mask<br>7. Single elastic head strap | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(White spundbond polypropylene,<br>meltblown polypropylene)<br>3. Tie wire nose piece<br>4. White elastic headband<br>5. Dimension<br>Small (13.5" circumference)<br>Large(15.5" circumference)<br>6. Flat pleated mask<br>7. Dual elastic head strap |
| NIOSH<br>certification# | TC-84A-4336 | TC-84A-2630 |
| Manufacturer | Shanghai Dasheng Health Products<br>Manufacture Co.,Ltd | Gerson Isolair APR Company<br>Predicate device-for reference |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | DTC3M-1 N95 Surgical Mask<br>(New device) | N95 model 2735 |
| 510K Number | | K960778 |
| Product code | MSH, 878.4040 | SAME |
| Device<br>Description | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(white polypropylene, non-woven PP micro fiber meltblown, Terylene)<br>3. Plastic nose wire<br>4. Natural rubber, latex free<br>5. Dimension<br>15.75" circumference<br>6. Molded Cup<br>7. Dual elastic head strap | 1. N95 Class Particuliar respirator<br>2. Multi-layer filteirng media<br>(White nonwoven polyester meltblown polypropylene)<br>3. Plastic nose wire<br>4. Yellow elastic, latex free<br>5. Dimension<br>Small (13.75" circumference)<br>6. Molded Cup<br>7. Dual elastic head strap |
| NIOSH<br>certification# | TC-84A-4331 | TC-84A-160 |
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# Shanghai Dasheng Health Products Manufacture Co.,Ltd K090131
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 3 of 3
| Manufacturer | Shanghai Dashèng Health Products<br>Manufacture Co.,Ltd | Tucker & Associates company for<br>Predicate device-for reference |
|-----------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------|
| Device | Flat surgical mask white, yellow, pink, blue,<br>orange, green(New device) | Surgical Face Mask colors; white, yellow,<br>pink, blue and green |
| 510K Number | | K022256 |
| Product code | MSH, 878.4040 | SAME |
| Device<br>Description | 1. Multi-layer filteirng media | 1. Multi-layer filteirng media |
| | 2. Plastic nose wire | 2. Plastic nose wire |
| | 3. Flat pleated | 3. Flat pleated |
| | 4. loops or strips | 4. loops or strip |
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are as follows:
- I. NIOSH, Exhalation of Resistance Test, 84.180
- II. NIOSH Inhalation of Resistance Test, 84.180
- NIOSH Sodium Chloride (Nacl) -N95 84.181 III.
- IV. Flammibility, Complied with 16 CFR 1610 Class I,
- V. Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.
Disscussion of Clinical Tests Performed.
Not Applicable
#### 7. Conclusions
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks have the same intended use and technology characterisitics as the predicate devices (K041855, K960778, K022256). Moreover, the bench testing contained in this submission supplied domonstrate that the technological characterisistics do not raise any new question of safety or effectiveness.
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks are substantially equivalent to the predicate devices.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## APR 2 7 2009
Ms. Maggie Zhong Shanghai Dasheng Health Products Number 228 Shihui Road Zhongshan Street Songjiang District Shanghai, CHINA
Re: K090131
Trade/Device Name: DS N95 Surgical Masks and Flat Surgical Masks for Single Use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH, FXX Dated: April 8, 2009 Received: April 13, 2009
Dear Ms. Zhong:
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 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.
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## Page 2- Ms. Zhong
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner, D.D.S., MA
Acting 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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## Attachment A
## INDICATIONS FOR USE
#### K090131 510(k) NUMBER (IF KNOWN):_
Shanghai Dasheng Health Products Manufacture Co.,Ltd APPLICANT:
DEVICE NAME:
DS N95 Surgical Masks and Flat Surgical Masks for single use
DTC3M-1, DTC3B Surgical N95 Respirator
DS Surgical Far Loop Masks - Blue(FE3B), Grem(FE3S), Yellow(FE3Y), White(FE3W), Orange(FE3C)
DS Surgical Fog Free Ear-Loop Masks-Blue(FE3P-O), Gren(FE3G-O), White(FE3VH-O), Orange(FB3O-O), Yellow(FF3Y-O),
DS Surgical Bar-Loop Masks with splash rison- Blue(FE3R-A), Orange(FB30-A), white(FE3YL-A), Yellow(FE3Y-A), Green(FE3C-A), DS Surgical Tie-On Masks - Blue(FT3B), Pink(FT3P), Green(FT3G), Yellow(FT3Y), White(FT3W), grange(FT3Q),
DS Surgical Fog Free Tie-On Masks - BluefFT3P-O), Green(FT33-O), Green(FT33-O), White/FT3Y4-O), Orange(FT30-O),
DS Surgical Tie-On Masks with splash visor - Blue(FT3B-A), Yhite(FT3W-A), Yellow(FT3Y-A), Yellow(FT3Y-A), Green(FT3C-A), Green(FT3C-A), Green(FT3C-A), Green(FT3C-A), Green(FT
### INDICATION FOR USE:
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The Counter Use_X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrrence of CDRH, Office of Device Evaluation (ODE)
Dusha M. Murphy, R.
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devines Division of Ancol, Dental Devices
510(k) Number: K090131
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