(164 days)
Not Found
Not Found
No
The 510(k) summary describes a surgical gown, a physical barrier device, and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No.
The device is a surgical gown intended to protect against transfer of micro-organisms, body fluids, and particulate matter, not to treat or diagnose a disease or condition.
No
The device described, HM Surgical Gowns, is a protective garment worn during surgical procedures and does not perform any diagnostic functions.
No
The device description clearly states the device is a physical surgical gown made from fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gowns are for protecting surgical patients and operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter during surgical procedures. This is a protective barrier function, not a diagnostic function.
- Device Description: The description details the material and construction of the gowns, which are physical barriers.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- No Mention of IVD-Related Terms: The document does not contain any terms typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "analyzer," etc.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Surgical gowns do not perform this function.
N/A
Intended Use / Indications for Use
HM Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics.
Non-sterile HM surgical gowns are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and Sterile surgical gowns are to be sold directly to users after EtO sterlization validation to ISO 11135-1.
Gowns are provided as below:
Gown Family A: 960100/860100
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960102 | STERILE | Surgical Gown, Non Reinforced | M | BLUE |
| 960103 | STERILE | Surgical Gown, Non Reinforced | L | BLUE |
| 960104 | STERILE | Surgical Gown, Non Reinforced | XL | BLUE |
| 960105 | STERILE | Surgical Gown, Non Reinforced | XXL | BLUE |
| 860102 | NONSTERILE | Surgical Gown, Non Reinforced | M | BLUE |
| 860103 | NONSTERILE | Surgical Gown, Non Reinforced | L | BLUE |
| 860104 | NONSTERILE | Surgical Gown, Non Reinforced | XL | BLUE |
| 860105 | NONSTERILE | Surgical Gown, Non Reinforced | XXL | BLUE |
Gown Family B: 960200/860200
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960202 | STERILE | Surgical Gown, Fabric Reinforced | M | BLUE |
| 960203 | STERILE | Surgical Gown, Fabric Reinforced | L | BLUE |
| 960204 | STERILE | Surgical Gown, Fabric Reinforced | XL | BLUE |
| 960205 | STERILE | Surgical Gown, Fabric Reinforced | XXL | BLUE |
| 860202 | NONSTERILE | Surgical Gown, Fabric Reinforced | M | BLUE |
| 860203 | NONSTERILE | Surgical Gown, Fabric Reinforced | L | BLUE |
| 860204 | NONSTERILE | Surgical Gown, Fabric Reinforced | XL | BLUE |
| 860205 | NONSTERILE | Surgical Gown, Fabric Reinforced | XXL | BLUE |
Gown Family C: 960300/86000
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960302 | STERILE | Surgical Gown, Poly Reinforced | M | BLUE |
| 960303 | STERILE | Surgical Gown, Poly Reinforced | L | BLUE |
| 960304 | STERILE | Surgical Gown, Poly Reinforced | XL | BLUE |
| 960306 | STERILE | Surgical Gown, Poly Reinforced | XL, X-Long | BLUE |
| 860302 | NONSTERILE | Surgical Gown, Poly Reinforced | M | BLUE |
| 860303 | NONSTERILE | Surgical Gown, Poly Reinforced | L | BLUE |
| 860304 | NONSTERILE | Surgical Gown, Poly Reinforced | XL | BLUE |
| 860306 | NONSTERILE | Surgical Gown, Poly Reinforced | XL, X-Long | BLUE |
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
operating room personnel / operating room
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle with its wings spread, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the eagle graphic. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 20, 2012
Mr. Alan Yu Manager, Quality Assurance/Regulatory Affairs Changzhou Holymed Products Company, Limited 528 Changwu Road South Wujin District Changzhou, Jiangsu, China 213167
Re: K121998
Trade/Device Name: HM Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 27, 2012 Received: November 29, 2012
Dear Mr. Yu:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
1
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.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
K121998 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HM Surgical Gowns
Indications for Use:
HM Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.
HM Surgical Gowns are disposable, single use, sterile or nonsterile surgical gowns manufactured from nonwoven Spunbond-Meltblown-Spunbond (SMS) polypropylene fabrics.
Non-sterile HM surgical gowns are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and Sterile surgical gowns are to be sold directly to users after EtO sterlization validation to ISO 11135-1.
Gowns are provided as below:
Gown Family A: 960100/860100
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960102 | STERILE | Surgical Gown, Non Reinforced | M | BLUE |
| 960103 | STERILE | Surgical Gown, Non Reinforced | L | BLUE |
| 960104 | STERILE | Surgical Gown, Non Reinforced | XL | BLUE |
| 960105 | STERILE | Surgical Gown, Non Reinforced | XXL | BLUE |
| 860102 | NONSTERILE | Surgical Gown, Non Reinforced | M | BLUE |
| 860103 | NONSTERILE | Surgical Gown, Non Reinforced | L | BLUE |
| 860104 | NONSTERILE | Surgical Gown, Non Reinforced | XL | BLUE |
| 860105 | NONSTERILE | Surgical Gown, Non Reinforced | XXL | BLUE |
Page 1 of 2
3
Gown Family B: 960200/860200
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960202 | STERILE | Surgical Gown, Fabric Reinforced | M | BLUE |
| 960203 | STERILE | Surgical Gown, Fabric Reinforced | L | BLUE |
| 960204 | STERILE | Surgical Gown, Fabric Reinforced | XL | BLUE |
| 960205 | STERILE | Surgical Gown, Fabric Reinforced | XXL | BLUE |
| 860202 | NONSTERILE | Surgical Gown, Fabric Reinforced | M | BLUE |
| 860203 | NONSTERILE | Surgical Gown, Fabric Reinforced | L | BLUE |
| 860204 | NONSTERILE | Surgical Gown, Fabric Reinforced | XL | BLUE |
| 860205 | NONSTERILE | Surgical Gown, Fabric Reinforced | XXL | BLUE |
Gown Family C: 960300/86000
| PROD. CODE | STERILE/NONSTERILE | DESC. | SIZE | COLOR |
|---|---|---|---|---|
| 960302 | STERILE | Surgical Gown, Poly Reinforced | M | BLUE |
| 960303 | STERILE | Surgical Gown, Poly Reinforced | L | BLUE |
| 960304 | STERILE | Surgical Gown, Poly Reinforced | XL | BLUE |
| 960306 | STERILE | Surgical Gown, Poly Reinforced | XL, X-Long | BLUE |
| 860302 | NONSTERILE | Surgical Gown, Poly Reinforced | M | BLUE |
| 860303 | NONSTERILE | Surgical Gown, Poly Reinforced | L | BLUE |
| 860304 | NONSTERILE | Surgical Gown, Poly Reinforced | XL | BLUE |
| 860306 | NONSTERILE | Surgical Gown, Poly Reinforced | XL, X-Long | BLUE |
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 2 of 2
Elizabeth F. Claverie
2012.12.19 21:51:29 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infaction Control, Dental Devices
510(k) Number;