VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
K040333 · Valumax Intl., Inc. · FXX · Jun 7, 2004 · General, Plastic Surgery
Device Facts
Record ID
K040333
Device Name
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
Applicant
Valumax Intl., Inc.
Product Code
FXX · General, Plastic Surgery
Decision Date
Jun 7, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
The following ValuMax" Surgical Masks are intended for use 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 materials. - ValuMax" Surgical Ear Loop Masks Blue, Pink, Green, Yellow, White, Peach . - ValuMax Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach . - ValuMax" Surgical Tie-On Masks Blue, Pink, Green, Yellow, White, Peach . - ValuMax" Surgical Fog Free Tie-On Masks Blue, Pink, Green, Yellow, White . - ValuMax" Surgical Ear-Loop Masks with splash visor Blue, Pink, Peach . - ValuMax" Surgical Tie-On Masks with splash visor Blue, White, Peach .
Device Story
ValuMax Surgical Masks are pleated 3-ply face masks designed for use by operating room personnel. Construction consists of inner/outer layers of medical grade tissue or spun-bond polypropylene and a middle layer of meltblown polypropylene filter media. Variants include ear-loop or tie-on attachments, anti-fog strips, and integrated anti-fog splash visors. The nose piece is a malleable aluminum wire. The device acts as a physical barrier to reduce the transfer of microorganisms, body fluids, and particulates between the wearer and the surgical environment. It is a single-use, non-sterile or sterile (as applicable) disposable device.
Clinical Evidence
No clinical data. Bench testing only, including BFE, Delta P, PFE, flammability, biocompatibility per ISO 10933, and synthetic blood penetration resistance.
Technological Characteristics
Pleated 3-ply construction. Materials: medical grade tissue or 100% spun-bond polypropylene (inner/outer layers), 100% meltblown polypropylene (filter layer). Malleable aluminum nose wire. Latex-free elastic ear-loops or tie-on straps. Anti-fog strips and anti-fog treated plastic splash visors on specific models. Biocompatibility per ISO 10933.
Indications for Use
Indicated for use by operating room personnel during surgical procedures to protect the patient 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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# ValuMax International Inc.
848 Hausman Road. Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288
## C. 510(K) SUMMARY- Revised 5-6-04
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 K040333
#### 1. Submitter & Foreign Manufacturer Identification
Qing Dao Tong Hui Clothing Co., Ltd. Xue-Chi Road, Hong Dao Industrial Park, Cheng Yang District, Qing Dao, Shan Dong, China 266114 Tel: 86-532-7937188 Fax: 86-532-7937288 Submitter's FDA Registration Number: 9616875
### 2. US Agent & Applicant
ValuMax International Inc. 848 Hausman Road Allentown PA 18104 Fax: 610-336-0102 Tel: 610-336-0101
#### 3. Contact Person
Ms. Janet Jia. President ValuMax International Inc. 848 Hausman Road Allentown PA 18104 Tel: 610-336-0101 Fax: 610-336-0102
Date of Summary: January 21, 2004
### 4. Name of the Device:
- ValuMax " Surgical Ear Loop Masks Blue, Pink, Green, Yellow, White, Peach ●
- ValuMax" Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach .
- ValuMax Surgical Tie-On Masks Blue, Pink, Green, Yellow, White, Peach ●
- ValuMax Surgical Fog Free Tie-On Masks Blue, Pink, Green, Yellow, White .
- ValuMax" Surgical Ear-Loop Masks with splash visor Blue, Pink, Peach ●
- ValuMax" Surgical Tie-On Masks with splash visor Blue, White, Peach ●
{1}------------------------------------------------
# ValuMax International Inc.
848 Hausman Road, Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288
## C. 510(K) SUMMARY - Continued
### 5. Classification Name: Mask, Surgical
#### 6. Predicate Device Information: K012602 - Crosstex Surgical Masks
#### 7. Device Description:
ValuMax" Surgical Masks are pleated 3-ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% meltblown polypropylene filter media. Ear-loops are made of soft latex free elastic loops. The nose piece for all ValuMax® Face Masks is malleable aluminum 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 ValuMax® Surgical Masks are being used in currently marketed devices (see predicate information).
### 8. Intended Use - Revised on 5-27-2004:
The following ValuMax" Surgical Masks are intended for use 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 materials.
- ValuMax" Surgical Ear Loop Masks Blue, Pink, Green, Yellow, White, Peach .
- ValuMax Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach .
- ValuMax" Surgical Tie-On Masks Blue, Pink, Green, Yellow, White, Peach .
- ValuMax" Surgical Fog Free Tie-On Masks Blue, Pink, Green, Yellow, White .
- ValuMax" Surgical Ear-Loop Masks with splash visor Blue, Pink, Peach .
- ValuMax" Surgical Tie-On Masks with splash visor Blue, White, Peach .
#### 9. Comparison to Predicate Devices:
See previous attached documents
{2}------------------------------------------------
# ValuMax International Inc.
848 Hausman Road, Allentown PA 18104 Tel: 86-532-7937188 Fax: 86-532-7937288
## C. 510(K) SUMMARY - Continued
## 10. Discussion of Non-Clinical Tests Performed for Dertermination of Substantial Equivalent are as Follows:
- Bacterial Filtration Efficiency (BFE) a.
- Pressure Differential (Delta P) b.
- c. Latex Particle Challenge (PFE)
- d. Flammability
- Biocompatibility per ISO 10933 e.
- Fluid Resistant Synthetic Blood Penetration Resistant Test f.
It is our conclusion that Performance Testing met all relevant requirements of the aforementioned test standards.
## 11. Discussion of Clinical Tests Performed:
Not Applicable
#### 12. Conclusions:
The ValuMax" Surgical Masks have the same intended use and technological characteristics as the predicate devices. Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. The ValuMax® Surgical Masks are substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2004
Ms. Janet Jia President ValuMax International, Incorporated 848 Hausman Road Allentown, Pennsylvania 18104
Re: K040333
Trade/Device Name: Valumax Surgical Masks (Blue, Pink, Green, Yellow, White and Peach) with or without Visors, Ties and Earloops. Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: May 27, 2004 Received: June 1, 2004
Dear Ms. Jia:
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 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 (1 Nr.), it may of bacyoo in the Code of Federal Regulations, Title 21, Parts 800 to 898. In Jour act FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 - Ms. Jia
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and registments, including, but not limited to: registration You must comply with an the rice b required (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), abouting (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality bjocks. (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) IThis letter will anow you to ough mading of substantial equivalence of your device to a premarket notification. - The PDF innulis 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), If you desire specific at 7.0 Tompliance 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 may oveant other generalational 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,
Chris Liu, 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
{5}------------------------------------------------
#### Indications for Use
## 510(k) Number: K040333
#### Device Name:
ValuMax® Surgical Ear Loop Masks -- Blue, Pink, Green, Yellow, White, Peach ValuMax® Surgical Fog Free Ear-Loop Masks- Blue, Pink, Green, White, Peach ValuMax® Surgical Tie-On Masks - Blue, Pink, Green, Yellow, White, Peach ValuMax Surgical Fog Free Tie-On Masks - Blue, Pink, Green, Yellow, White ValuMax® Surgical Ear-Loop Masks with splash visors - Blue, Pink, Peach ValuMax® Surgical Tie-On Masks with splash visors - Blue, White, Peach
#### Indications For Use:
ValuMax" Surgical Masks is 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 materials.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kain Mulvey
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K040333
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