(322 days)
Not Found
No
The device description and intended use clearly describe surgical gowns, which are physical barriers and do not involve any computational or analytical functions. There is no mention of AI or ML in the document.
No.
The device is a surgical gown intended to protect healthcare workers and patients from microorganisms and fluids, not to treat or diagnose a disease or condition.
No
The device is a surgical gown, which is a protective apparel used to prevent the transfer of microorganisms and fluids during medical procedures. Its intended use is not for diagnosing a disease or condition.
No
The device description clearly states the device is a physical surgical gown made of nonwoven fabric and includes reinforced material sheets. It is a tangible, hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are "intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter." This describes a barrier function for personal protection, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical characteristics of the gowns (fabric, construction, sizes, closures), which are consistent with protective apparel, not diagnostic equipment or reagents.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on physical properties like barrier performance, tensile strength, flammability, and biocompatibility, which are relevant to protective clothing, not diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This description clearly falls outside that scope.
N/A
Intended Use / Indications for Use
The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification.
The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. *
*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.
These gowns are for single use.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The 3M surgical gowns are sterile, disposable and intended for single use. They come in a variety of sizes (M, L, XL and XXL). Their construction includes a blue nonwoven fabric consisting of either a SMMS or Spunlace. Those gowns that are labeled reinforce include extra reinforced material sheets integrated into parts of the gown within the front panel and on both sleeves from the cuff to the elbow. The gowns include a specific AAMI Liquid Barrier Performance and Classification (i.e. 2 or 4) Level. All gowns are easy to don and include a hook and loop to close the neck and ties for closing the back of the gown. They include functional cuffs constructed of a white knitted material.
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
health care professionals
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)
The surgical qowns testing includes; biocompatibility, linting and cleanliness - particular matter, tensile strength, flammability and ANSI/AMMI PB70:2003 liquid barrier performance. All results of the testing met acceptable and/or required criteria.
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.
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
Premarket Notification 510(k) Summary
101468
APR 1 4 2011
| Sponsor Information: | 3M Health Care
3M Center, Bldg. 275-5W-06
St. Paul, MN 55144-1000 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Linda Johnsen
Regulatory Affairs Specialist
Phone Number: (651) 737-4376
FAX Number: (651) 737-5320 |
| Date of Summary: | October 6, 2010 |
| Device Common Name: | Sterile Disposable Surgical Gowns |
| Proprietary Name: | 3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494)
3M™ HP Disposable Surgical Gown (REF 7691C, 7692C,
7693C & 7694C)
3M™ Reinforced Disposable Surgical Gown (REF 7595C,
7596C, 7597C & 7598C)
3M™ Disposable Surgical Gown (REF 7591C, 7592C, 7593C,
& 7594C)
3M™ HP Reinforced Disposable Surgical Gown (REF 7695C,
7696C, 7697C, & 7698C) |
| Classification Name: | Surgical Apparel (Class II, 21 CFR § 878.4040) |
| Product Code: | FYA |
| Performance Standards: | None |
| Predicate Device: | Kimberly Clark, Ultra Film-Reinforced Surgical Gown (K080795) |
Intended Use:
The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAM Liquid Barrier Classification.
The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. *
*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.
These gowns are for single use.
1
Description of Device:
The 3M surgical gowns are sterile, disposable and intended for single use. They come in a variety of sizes (M, L, XL and XXL). Their construction includes a blue nonwoven fabric consisting of either a SMMS or Spunlace. Those gowns that are labeled reinforce include extra reinforced material sheets integrated into parts of the gown within the front panel and on both sleeves from the cuff to the elbow. The gowns include a specific AAMI Liquid Barrier Performance and Classification (i.e. 2 or 4) Level. All gowns are easy to don and include a hook and loop to close the neck and ties for closing the back of the gown. They include functional cuffs constructed of a white knitted material.
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
| Element | 3M Basic
Disposable
Surgical
Gown | 3M
Disposable
Surgical
Gown | 3M
Reinforced
Disposable
Surgical
Gown | 3M HP
Disposable
Surgical
Gown | 3M HP
Reinforced
Disposable
Surgical
Gown | K080795
KC-Ultra Film
Reinforce
Surgical Gown |
|-------------------------------------------|--------------------------------------------|--------------------------------------|----------------------------------------------------|-----------------------------------------|-------------------------------------------------------|--------------------------------------------------------|
| Cat #'s | 7492
7493
7494 | 7591C
7592C
7593C
7594C | 7595C
7596C
7597C
7598C | 7691C
7692C
7693C
7694C | 7695C
7696C
7697C
7698C | |
| Intended Use | Same | Same | Same | Same | Same | Same |
| Sterile | Yes | Yes | Yes | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes | Yes | Yes | Yes |
| Disposable | Yes | Yes | Yes | Yes | Yes | Yes |
| AAMI Fluid
Barrier
Protection Level | Level 2 | Level 2 | Level 4 | Level 2 | Level 4 | Level 4 |
| Flammability
Level | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 |
| Materials | Nonwoven
SMMS | Nonwoven
Spunlace | Nonwoven
Spunlace | Nonwoven
SMMS | Nonwoven
SMMS | Nonwoven
SMS |
| Optional Sizes
(i.e. L) | Yes | Yes | Yes | Yes | Yes | Yes |
| hook-and-loop
neck closure | Yes | Yes | Yes | Yes | Yes | Yes |
| Tie waist closure | Yes | Yes | Yes | Yes | Yes | Yes |
| Reinforcement | No | No | Yes* | No | Yes* | Yes |
| Cuffs | Yes | Yes | Yes | Yes | Yes | Yes |
| Gown Color | Blue | Blue | Blue | Blue | Blue | Blue |
*Note: Include a reinforced panel on the inside of the gown within the front panel and sleeves from the cuff to the elbow.
Summary of Testing:
The surgical qowns testing includes; biocompatibility, linting and cleanliness - particular matter, tensile strength, flammability and ANSI/AMMI PB70:2003 liquid barrier performance. All results of the testing met acceptable and/or required criteria.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Linda Johnson Regulatory Affairs Specialist 3M Company Corporation 3M Center, Building 275-5W-06 St Paul, Minnesota 55144-1000
APR 1 4 2011
Re: K101468
Trade/Device Name: 3M™ Surgical 3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494) 3MTM HP Disposable Surgical Gown (REF 7691C, 7693C & 7694C) 3M™ Reinforced Disposable Surgical Gown (REF 7595C, 7597C, & 7598C) 3MTM Disposable Surgical Gown (REF 7591C, 7592C, 7593C, & 7594C) 3M™ HP Reinforced Disposable Surgical Gown (REF7695C, 7696C 7697C & 7698C) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 5, 2011 Received: April 6, 2011
Dear Ms. Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 - Ms. Johnson
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/Industrv/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if Known):
Device Name: 3M™ Surgical Gowns
3M™ Basic Disposable Surgical Gown (REF 7492, 7493 & 7494) 3M™ HP Disposable Surgical Gown (REF 7691C, 7692C, 7693C & 7694C) 3M™ Reinforced Disposable Surgical Gown (REF 7595C, 7596C, 7597C, & 7598C) 3M™ Disposable Surgical Gown (REF 7591C, 7592C, 7593C, & 7594C) 3M™ HP Reinforced Disposable Surgical Gown (REF 7695C, 7696C 7697C, & 7698C)
Intended Use
The 3M™ Basic Disposable Surgical Gowns, 3M™ Disposable Surgical Gowns and 3M™ HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification.
The 3M™ Reinforced Disposable Surgical Gowns and 3M™ HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood. These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns. *
*To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow.
These gowns are for single use.
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) | |||||
|---|---|---|---|---|---|
| 2007 | 11 To Clawiter in . | 110.18- | Career of the Property of Children |
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1R
510(k) Number: K101468