(37 days)
Not Found
Not Found
No
The 510(k) summary describes a physical respirator mask and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a respirator mask intended to protect users from the transfer of microorganisms, body fluids, and particulate material, not to treat a health condition.
No
Explanation: This device is described as a respirator mask for protection against microorganisms and particulate material, not for diagnosing any medical condition.
No
The device description clearly outlines physical components like filter media, headbands, and nose/chin wires, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the Alpha Pro Tech 695 N95 Respirator Mask clearly state its purpose is to be worn on the face to filter airborne particles and protect against the transfer of microorganisms and fluids. It is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing bodily fluids, or providing diagnostic information based on laboratory analysis.
Therefore, based on the provided information, the Alpha Pro Tech 695 N95 Respirator Mask is a personal protective equipment (PPE) device, specifically a respirator and surgical mask, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Alpha Pro Tech's 695 N95 Respirator Masks meet the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are 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. Intended use includes use as a procedure mask, isolation mask and/or dental face mask. The 695 mask is a single use, disposable device.
Product codes (comma separated list FDA assigned to the subject device)
MSH
Device Description
Alpha Pro Tech's 695 N95 Respirator Masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands. Fitting around the face is facilitated using a nose wire and an adjustable chin wire made from aluminum. No fiberglass media is used in this product.
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
healthcare personnel / healthcare facilities
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 1 2009
Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch
SECTION 5 510(k) SUMMARY
Submitter:
Alpha Pro Tech, Inc. 236 North 2200 West Salt Lake City, Utah 84116 Registration Number 1721663
Contact:
David Kitchen Corporate QA/RA Manager Telephone: 801.355.5816 Fax: 801-355-2534 E-mail: dkitchen@alphaprotech.com
Trade Name:
Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch
Model Numbers:
ക്കട
Common Name:
Healthcare N95 Particulate Respirator Mask
Predicate Device:
Alpha Pro Tech's 695 N95 Respirator Mask has the same technological characteristics as Aearo Company's Pleats Plus 1050 Respirator Masks in that both are NIOSH approved; both are made of nonwoven meltblown polypropylene; both incorporate a forming nosepiece, both employee a flat pleated style; and both are secured using dual elastic head straps.
Classification:
Device Class - Class II Product Code - MSH - Surgical N95 Respirator CFR Section - 21 CFR 878.4040
Device Description:
Alpha Pro Tech's 695 N95 Respirator Masks consists of a polypropylene meltblown filter media sandwiched between non-woven wetlaid outer and inner covers. The mask is secured using two polyester covered non-latex rubber headbands. Fitting around the face is facilitated using a nose wire and an adjustable chin wire made from aluminum. No fiberglass media is used in this product.
Intended Use:
Alpha Pro Tech's 695 N95 Respirator Masks meet the CDC guidelines for TB Exposure Control within healthcare facilities. These devices are intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of
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AlphaProTec
Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch
microorganisms, body fluids, and particulate material. Intended use includes use as a procedure mask, isolation mask and/or dental face mask. The 695 mask is a single use, disposable device.
Limitations:
The application of the 695 mask does not eliminate the risk to the wearer of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. David Kitchen Corporate Ouality Assurance/Regulatory Affairs AlphaProTech, Incorporated 236 North 2200 West Salt Lake City, Utah 84116
OCT 2 1 2009
Re: K092824
Trade/Device Name: Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch Regulation Number: 21CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: October 1, 2009 Received: October 7, 2009
Dear Mr. Kitchen:
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.
3
Page 2- Mr. Kitchen
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Century D. mark for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Abbreviated 510(k) For Alpha Pro Tech, Inc 695 N95 Respirator Mask with Positive Facial Lock and Magic Arch
SECTION 4 INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: Alpha Pro Tech 695 N95 Respirator Mask, Positive Facial Lock with Magic Arch
Indications for Use:
Alpha Pro Tech's 695 N95 Respirator Mask meets the 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. It is intended to be a single use, disposable device. This would also include use as a procedure mask, isolation mask and/or dental face mask.
Prescription Use (Part 21 CFR 801 Subpart-D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Shule A. Murphy Co
ence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Anesthesiology. General Horpits! Infection Control, Dental Devices
510(k) Number: K092824
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