← Product Code [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH) · K062663 # MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS (K062663) _Moldex/Metric, Inc. · MSH · Oct 11, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K062663 ## Device Facts - **Applicant:** Moldex/Metric, Inc. - **Product Code:** [MSH](/submissions/SU/subpart-e%E2%80%94surgical-devices/MSH.md) - **Decision Date:** Oct 11, 2006 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 878.4040 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** 3rd-Party Reviewed ## Intended Use The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. ## Device Story Molded cup-style N95 particulate respirator and surgical mask; constructed from extruded plastic mesh outer cover, nonwoven spunbond inner/outer layers, and polypropylene melt-blown filter media; features non-latex rubber head straps and closed-cell polyethylene foam nosepiece. Used in healthcare facilities by personnel during surgical procedures or for TB exposure control. Acts as physical barrier to microorganisms, body fluids, and particulates. NIOSH-certified (TC-84A-4339) for 95% filtration efficiency against 0.055–0.095 micron particles. Protects wearer and patient from cross-contamination; does not eliminate disease risk. Requires immediate replacement if contaminated. ## Clinical Evidence Bench testing only. No clinical data. Performance verified via NIOSH 42 CFR Part 84 (filtration efficiency >95%, breathing resistance <35 mm H2O), ASTM F1862 (synthetic blood penetration), 16 CFR 1610 (flammability), and ISO 10993 (biocompatibility). Bacterial filtration efficiency >99.9% per Modified Greene and Vesley Method. ## Technological Characteristics Molded cup design; materials: extruded ethylene-vinyl acetate copolymer (outer), nonwoven spunbond (inner/outer), polypropylene melt-blown (filter), polyethylene foam (nosepiece), non-latex rubber (straps). NIOSH-certified (TC-84A-4339). Meets ASTM F1862 for fluid resistance and 16 CFR 1610 for flammability. Biocompatibility per ISO 10993-1. ## Regulatory 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 - Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1511, 1512, 1517 ([K061859](/device/K061859.md)) - Inovel Health Care N95 Particulate Respirators and Surgical Masks models 3001N95-S, 3002N95-M, 3003N95-L, 3004N95-LP ([K051182](/device/K051182.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K062663'. The characters are written in black ink on a white background. The handwriting style is casual and slightly uneven. Image /page/0/Picture/1 description: The image shows the word "MOLDEX" in a bold, sans-serif font. Below the word "MOLDEX" is the phrase "ideas that work well" in a smaller, lighter font. The text is slightly blurred, giving it a textured appearance. The overall design is simple and clean, with a focus on the brand name. MOLDEX-METRIC, INC. 10:11 West Jefferson Boxlevard. Culver City, Ceilfornia 90232 TEL 310-837-6500 FAX 310-837-9563 www.moldex.com August 11, 2006 12 - 1 # 510(k) Summary Submitter: Moldex-Metric, Inc 10111 W. Jefferson Blvd. Culver City, CA 90232-3509 OCT 1 1 2006 Contact: William Wawrzyniak Director Quality Assurance Telephone: 310-837-6500 Ext. 705 Fax: 310-837-0468 E-mail: williamw(@moldex.com Trade Name: Moldex Health Care N95 Particulate Respirators and Surgical Masks, various models # Common Name: Health Care N95 Particulate Respirators and Surgical Masks Classification: Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section - 21 CFR 878.4040 # Substantial Equivalency: Moldex Health Care N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1511, 1512, 1517 [(510(k) K061859] and 3001N95-S, 3002N95-M, 3003N95-L. 3004N95-LP [(510(k) K051182]. These products have also been tested and approved by NIOSH as N95 Respirators. {1}------------------------------------------------ KC 6263 MOLDEX-METRIC, INC. 10111 West Jefferson Boulevard, Culver Dity, California 90232 TEL 310-837-6500 FAX 310-837-9563 www.moldex.com Image /page/1/Picture/3 description: The image shows the word "MOLDEX" in a stylized font. Below the word "MOLDEX" is the phrase "ideas that wear well." The text is in a dark color, contrasting with the background. 510(k) Summary (Continued) 12 - 2 Description: The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown fitter media is layered between the inner and outer cover. The head straps are made of a non-latex rubber stapled to the mask, The inside nosepiece is a closed cell foam. The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification number is TC-84A-4339. The type N95 must meet the preseribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resintance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The devices have a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted by Nelson Laboratories using the Modified Green and Vesley Method for evaluation of bacterial filtration efficiency of surgical masks. #### Intended Use; The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healtheare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. ### Limitations: These products do not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids. ### Comparison of Predicate Devices: The outside cover of the previously cleared devices incorporate an extruded plastic mesh or a nonwoven polypropylene material with a layer of an extruded plastic mesh and the Moldex models 2211GN95-S, 2212GN95-M/L and 2217GN95-LP an extruded plastic mesh on the outside cover. The head strap color of the cleared device is the same as the Inovel device models for which clearance is being requested. The Inovel type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 -- 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510/k) are manufactured from similar materials. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains handwritten text that appears to read "KOL 2663". The characters are written in a cursive style, with some connections between the letters. The text is slightly slanted and has varying stroke thicknesses, suggesting it was written with a pen or marker. Image /page/2/Picture/1 description: The image shows the word "MOLDEX" in a bold, sans-serif font. Below the word "MOLDEX" is the phrase "Ideas that wear well." in a smaller, lighter font. The text appears to be slightly pixelated, giving it a textured look. The overall impression is of a logo or brand name with a tagline. MOLDEX-METRIC. INC. 19111 West Jatterson Boulevard. Culver City, California 90232 FAX 310-837-9563 www.moldex.com TEL 310-837-5500 12-3 # 510(k) Summary (continued) # Device and Predicate Devices Descriptions/ Comparisons | Description | Moldex Health Care N95
Particulate Respirators and
Surgical Masks, models
2211GN95-S, 2212GN95-M/L,
2217GN95-LP | Inovel Health Care N95
Particulate Respirators and
Surgical Masks, models 1511,
1512, 1513, 1517 | Inovel Health Care N95
Particulate Respirators and
Surgical Masks, models
3001N95-S, 3002N95-M,
3003N95-L, 3004N95-LP | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Materials | | | | | Outer Cover
Fabrics | Ethylene-Vinyl Acetate
Copolymer, extruded | Ethylene-Vinyl Acetate
Copolymer, extruded | Polypropylene Spunbond and
Ethylene-Vinyl Acetate
Copolymer, extruded | | Nosepiece | Polyethylene foam | Polyethylene foam | Polyethylene foam | | Headband | Various colors elastic, latex free | Various colors elastic, latex free | Various colors elastic, latex free | | Specification &
Dimensions | Overall width: 5 - 5 5/8 inches
Overall height:
4 3/4 - 5 1/2 inches | Overall width: 5 - 5 5/8 inches
Overall height:
4 3/4 - 5 1/2 inches | Overall width: 5 - 5 5/8 inches
Overall height:
4 3/4 - 5 1/2 inches | | Mask Style | Molded Cup | Molded Cup | Molded Cup | | Design Features | Dual synthetic rubber head
straps | Dual synthetic rubber head straps | Dual synthetic rubber head
straps | | NIOSH Certification# | TC-84A-4339 | TC-84A-0013 | TC-84A-4102 | # Risks to Health | Performance
Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results | |-------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | | | Moldex Health Care N95
Particulate Respirators and
Surgical Masks various
models (3) | Inovel Health Care N95
Particulate Respirators and
Surgical Masks models 1511,
1512, 1513, 1517 | Inovel Health Care N95
Particulate Respirators and
Surgical Masks models
3001N95-S, 3002N95-M,
3003N95-L, 3004N95-LP | | Fluid Resistance
Performance | ASTM 1862 -
00a | 32 of 32 pass | Models 1511, 1513 and 1517
32 of 32 pass
Model 1512
31 of 32 pass | 32 of 32 pass | | Flammability Class | 16 CFR 1610 | Flame spread must be within
upper and lower limits/ No
flame spread on 10 of 10
samples, meets Class I | Flame spread must be within
upper and lower limits/ No
flame spread on 10 of 10
samples, meets Class I | Flame spread must be within
upper and lower limits/ No
flame spread on 10 of 10
samples, meets Class I | | Filter Efficiency (%) | NIOSH, 42 CFR
Part 84 | > 95% Efficient/ average
96.81% efficient of 20
samples | > 95% Efficient/ average
98.58% efficient of 17
samples | > 95% Efficient/ average
99.11% efficient of 20
samples | | Breathing
Resistance
(mm H₂O) | NIOSH, 42 CFR
Part 84 | < 35.0 mm H₂O @ 85 lpm/
average 10.2 mm H₂O @ 85
lpm of 3 samples | < 35.0 mm H₂O @ 85 lpm/
average 10.3 mm H₂O @ 85
lpm of 3 samples | < 35.0 mm H₂O @ 85 lpm/
average 11.3 mm H₂O @ 85
lpm of 3 samples | | Biocompatibility * | ISO 10993 - 1 | Cytotoxicity
Same as predicate device | Cytotoxicity, score of 2 or
less/ Score of 0 | Cytotoxicity, score of 2 or
less/ Score of 0 | | | | Sensitization
Same as predicate device | Sensitization, Grade 1 (no
different than control)/ Grade
1 | Sensitization, Grade 1 (no
different than control)/ Grade
1 | | | | Primary Skin Irritation
Same as predicate device | Primary Skin Irritation,
Negligible/Negligible | Primary Skin Irritation,
Negligible/Negligible | | Bacterial Filtration
Efficiency | Modified Greene
and Vesley
Method. J
Bacteriol 83:663-
667. | Test results show a bacterial
filtration efficiency greater
than 99.9% | Test results show a bacterial
filtration efficiency greater
than 99.9% | Test results show a bacterial
filtration efficiency greater
than 99.9% | * Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "MOLDEX" in a textured font. Below the word "MOLDEX" is the phrase "Ideas that is our Wi-fi". The text is in a dark color, contrasting with the white background. The image appears to be a logo or branding element. MOLDEX-METAIC、INC 1911: Wast selfrison Satievard Suiver Sat. FAx 310-837-9563 Parse mailies & 151 310-837-6500 12 -- 4 #### 510(k) Summary (Continued) #### Performance Tests: These products were tested and certified by NIOSH as an approved N95 Respirator. It meets all the requirements prescribed in 42 CFR Part 84 and is assigned TC-84A-4339 Tests Performed Laboratory Nelson Laboratories Northview Northview Pacific Pacific (Coordinated by Nelson Laboratories) Laboratories, Laboratories. Inc. Inc. - 1. Fluid Resistance Resistance of Liquid Moldex-Metric Inc. (Synthetic Blood Penetration Resistance) ASTM F 1862. - (Particulate and NIOSH Efficiency Filtration ni Bacterial) 42 CFR Part 84 - Differential Pressure (Delta P) Breathing NIOSH 3. Resistance 42 CFR Part 84 - Nelson Laboratories 4. Flammability 16 CFR 1610 (Class I) - Biocompatibility* (tested on র্থ predicate devices) - Cytotoxicity (ISO 10993-5) . - Sensitization (ISO 10993-10) * - Irritation (ISO 10993-10) . - (Coordinated by Nelson Laboratories) Nelson Laboratories Bacterial Filtration Efficiency Modified Greene and Vesley Method. J Bacteriol 83:663-667. * Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission. ### Safety/ Effectiveness: 6. r. The devices have a filtration equivalent to the previously cleared Inovel LLC N95 Particulate Respirators and Surgical masks models 1511, 1512, 1513, 1517 510(k) number K061859 and Models 3001N95-S, 3002N95-M, 3003N95-L and 3004N95-LP 510(k) number K051182. They are NIOSH approved and meet the CDC guidelines for TB. #### Conclusion: The basic construction and material used in the cleared devices are the same as in the new devices. The cleared devices and the new devices are also approved by NIOSH, and meets all other required tests. The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are substantially equivalent to those listed on page 2 - 4. {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Moldex-Metric, Incorporated C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087 OCT 1 1 2006 Re: K062663 Trade/Device Name: Moldex Health Care N95 Particulate Respirators and Surgical Mask, Models 2211GN95-S, 2212GN95-M/L, 2217GN95-LP Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: September 28, 2006 Received: September 29, 2006 Dear Mr. Devine: 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. {5}------------------------------------------------ # Page 2 - Mr. Devine 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Clive 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 {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K (002 Lle L 3 Device Name: Health Care N95 Particulate Respirators and Surgical Masks, models 2211GN95-S, 2212GN95-M/L, 2217GN95-LP Indications for Use: The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X . (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Stella A. Murphy, D 10/1/04 Division Sign-Off ision of Anesthesiology. General Hospital misction Control, Dental Devices Number: Y042 663 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K062663](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/MSH/K062663) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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