(148 days)
Not Found
No
The summary describes a standard surgical glove and its performance against established ASTM standards, with no mention of AI or ML capabilities.
No
A surgical glove is intended to protect against contamination and does not provide a therapeutic effect on a disease or condition.
No
Explanation: A diagnostic device is used to diagnose a condition, disease, or abnormal state. The provided text clearly states the device's intended use is "to protect a surgical wound from contamination," which is a protective function, not a diagnostic one.
No
The device description clearly states it is a physical product made of natural or synthetic rubber (surgical gloves) and includes performance studies related to physical characteristics and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties and materials of the glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical characteristics, safety (biocompatibility), and sterility of the glove, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The Surgical Glove is made of all natural rubber, sterife, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.
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
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 Powdered Latex Surgical Gloves Sterile: Powder Free Latex Surgical Gloves. Sterile with Protein Content Labeling Claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Dimensions: Meets ASTM D 3577-09e1
Physical Properties: Meets ASTM D 3577-09e1
Freedom from pinholes: Meets ASTM D 3577-09e1
Powder Residual: Meets ASTM D 6124-06
Protein Level: Meets ASTM D 5712-10
Biocompatibility: Primary Skin Irritation in Rabbits - Passes (Not a primary skin irritant); Dermal Sensitization - Passes (Not a primary skin irritant)
Sterilization Validation: Meets ISO 11137-2:2006
The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) are sterilized using 25 Kilograys of Gamma Radiation and have a Sterility Assurance Level (SAL) of 10-6. The sterilization cycle has been validated according to ISO 11137-2:2006 method.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
K113233
MAR 2 9 2012
510(k) SUMMARY
1.0 Submitter
| Name |
|---|
| Street Address |
| Phone No. |
| Fax No. |
Shen Wei (USA) Inc. 33278 Central Ave., Suite 102 Union City, CA. 94587 (510)429-8692 (510)487-5347
Date of Summary Prepared: 12/29/2010
Name and Location of Actual Manufacturers:
| Name | Zhenjiang Kangda Emulsion Co., Ltd. |
|---|---|
| Address | Lianhe Town, Yangzhong City, Zhenjiang |
| Country | China |
| Phone No. | (511)551-1390 |
| Fax No. | (511)832-2861 |
Zhengjiagang Dayu Rubber Products CO., LTD. Xizhang Town, Zhangjiagang City, Jiangsu China 520-945-0023 Phone No. Fax No. 520-845-0311
2.0 Contact Person:
Name:
Address Country
| Name: | Mr. Albert T Li |
|---|---|
| Phone No. | (510)429-8692 |
| Fax No. | (510)487-5347 |
3.0 Device Identification:
Glove Proprietary or Trade Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)
Common Name: Surgical Gloves
Classification Name: Surgeon's gloves - 21 CFR 878.4460
Predicate Device: K063757 Motex Powder-Free Surgical Gloves and Powdered Latex surgical Gloves
1
1
4.0 Identification of the Legally Marketed Device or Predicate Devices:
Class I Powder Free, Powdered natural rubber latex Surgeon's gloves, 79KGO, this surgical glove described in this 510(k) is substantially equivalent to K063757.
5.0 Description of the Device:
The Surgical Glove is made of all natural rubber, sterife, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.
6.0 Intended Use of Device:
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
7.0 Summary of Technological Characteristics for Modified Device:
The Powdered Latex Surgical Gloves Sterile: Powder Free Latex Surgical Gloves. Sterile with Protein Content Labeling Claim (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577-09e1 | Meets |
| Physical Properties | ASTM D 3577-09e1 | Meets |
| Freedom from pinholes | ASTM D 3577-09e1 | Meets |
| Powder Residual | ASTM D 6124-06 | Meets |
| Protein Level | ASTM D 5712-10 | Meets |
| Biocompatibility | Primary Skin Irritation | |
| in Rabbits | Passes | |
| (Not a primary skin | ||
| irritant) | ||
| Dermal Sensitization | Passes | |
| (Not a primary skin | ||
| irritant) | ||
| Sterilization Validation | ISO 11137-2:2006 | Meets |
8.0 Sterility:
2
2
Name of Sterilization Company: Yangzhou Irradiation Processing Center Address: No. 568, vangziliang North Road, Yangzhou, China Phone Number: 086-514-87300601
The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) are sterilized using 25 Kilograys of Gamma Radiation and have a Sterility Assurance Level (SAL) of 10-6.
The sterilization cycle has been validated according to ISO 11137-2:2006 method.
9.0 Packaging and Labeling:
The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) are packaged in sterilization pouches that are paper bags or paper/plastic bags and sealed and packaged into an outer carton. The entire carton is then sterilized by Gamma radiation specified in section 9.0. View Attachment 3 for labeling details.
10.0 Conclusion:
The Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less) will perform according to the glove performance standards reference in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices such as K063757.
ﺩﻣﺎ
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 9 2012
Mr. Albert Li Project Manager Shen Wei (USA) Inc. 33278 Central Ave. Suite 102 Union City, California 94587
Re: K113233
Trade/Device Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: March 13, 2012 Received: March 15, 2012
Dear Mr. Li:
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.
4
Page 2 - Mr. Li
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 yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment Two
INDICATION FOR USE
Applicant: Shen Wei (USA) Inc.
- Device Name: Powdered Latex Surgical Gloves Sterile; Powder Free Latex Surgical Gloves, Sterile with Protein Content Labeling Claim (50 micrograms or less)
Indication For Use:
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Elizabeth F. Claiborne Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 113233