(117 days)
No
The device is a surgical glove, and the description focuses on material properties and performance against standards, with no mention of AI or ML.
No
The device is a surgical glove used for protection, not for treating or diagnosing a medical condition.
No
Explanation: The device is a surgical glove, intended to protect surgical wounds from contamination during surgery. It does not perform any diagnostic function.
No
The device is a physical product (surgical gloves) made of natural rubber, 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 the device is "intended to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier function for protection, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the material (natural rubber), sterility, and compliance with a standard for surgical gloves (ASTM D 3577). There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In summary, the device is a surgical glove, which is a medical device used for protection, not for performing diagnostic tests outside of the body.
N/A
Intended Use / Indications for Use
The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are made of natural rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have yellow color.
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
Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine), manufactured by "Hebei HongSen Plastics Technology Co., Ltd." met all relevant requirements in the test standards, and are comparable to the predicate device.
Dimensions: Meets ASTM D 3577-09
Physical Property: Meets ASTM D 3577-09
Free of Pinhole: Meets ASTM D5151 (AQL 1.5)
Residue Powder: Meets ASTM D6124
Water Soluble Protein: Meets ASTM D5712-10
Primary Skin Irritation (ISO 10993-10: 2010): Not a primary skin irritant under the conditions of the study
Dermal sensitization (ISO 10993-10: 2010): Not a dermal sensitizer under the conditions of the study
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2014
Hebei HongSen Plastics Technology Company, Limited C/O Mr. Charles Shen Official Correspondent Manton Business and Technology Services 5 Carey Street Pennington, New Jersey 08534
Re: K140988
Trade/Device Name: Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 11, 2014 Received: July 15, 2014
Dear Mr. Shen:
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.
1
Page 2 - Mr. Shen
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. 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
510(k) Number (if known) K140988
Device Name
Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine)
Indications for Use (Describe)
The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Hebei HongSen Plastics Technology Co., Ltd The Eastern Industrial Accumulation Area Nangong Town, Xingtai City, Hebei Province, China Tel: 86- 311-85656588 Submitter's FDA Registration Number: 3010582952
5.2 US Agent and Contact Person
Charles Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: March 15, 2014
| 5.4 | Device Names: |
|---|---|
| ----- | --------------- |
| Proprietary Name: | Powder Free Sterile Latex Surgical Gloves, Yellow Color
(Brand Name: Titanfine) |
|------------------------|------------------------------------------------------------------------------------|
| Common Name: | Surgeon's glove |
| Classification Name: | Surgeon's glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 878.4460 |
| Panel: General | General & Plastic Surgery |
| Product Code: | KGO |
ર્સ્ટ Predicate Device Information:
(1) K121897, "Protexis' Latex Basic, Sterile Latex Powder-Free Surgical Glove with Protein Content Label Claim of 50ug/dm² or less (Cream)", manufactured by "Cardinal Health"
5.6 Device description:
Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are made of natural rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have yellow color.
4
5.7 Intended Use:
The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine) is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
న్ని ని Comparison to Predicate Devices
The powder free sterile latex surgical gloves, yellow, are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
K121897, "Protexis' Latex Basic, Sterile Latex Powder-Free Surgical Glove with Protein Content Label Claim of 50ug/dm² or less (Cream)", manufactured by "Cardinal Health"
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device (K121897) |
|---|---|---|
| Indication for Use | The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine) is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. |
| Basic Design | A garment covering the hand and waist area. Gloves have separate sheaths or openings for each finger and the thumb. | Same |
| Materials | Natural rubber | Same |
| Size | 6, 6.5, 7, 7.5, 8, 8.5, 9 | Information not available |
| Single Use | Yes | Yes |
| Color | Yellow | Cream |
| Sterile | Sterile (Irradiation) | Sterile |
Table 5.1: Comparison of Intended Use, Design, and Material
Our device is essentially identical to the predicate device in terms of indications for use, design, and material between our device and the predicate devices. The only minor difference is that the predicate device has cream color, while our device in submission has yellow color.
5
The following table shows similarities and differences of the performance between our device and the predicate devices. One minor difference is that predicate device has an extractable protein limit of 50 µg/dm², where our device has a limit of 200 µg/dm². This minor difference does not impact the safety of the device as 200 µg/dm² is still a well accepted safe limit.
Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine), manufactured by "Hebei HongSen Plastics Technology Co., Ltd." met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Our Device | Predicate Device (K121897) |
|---|---|---|
| Dimension | Meets ASTM D 3577-09 | |
| (Published 02/1/2009) | Meets ASTM D 3577 | |
| (Publication date unknown) | ||
| Physical Property | Meets ASTM D 3577-09 | |
| (Published 02/1/2009) | Meets ASTM D 3577 | |
| (Publication date unknown) | ||
| Free of Pinhole | Meets ASTM D5151 (AQL | |
| 1.5) | ||
| (Published 08/20/2012) | Meets ASTM D5151 | |
| (Publication date unknown) | ||
| Residue Powder | Meets ASTM D6124 | |
| (Published 08/20/2012) | Meets ASTM D6124 | |
| (Publication date unknown) | ||
| Water Soluble Protein | Meets ASTM D5712-10 | |
| (Published 02/01/2009) | Meets ASTM D5712 | |
| (Publication date unknown) | ||
| Primary Skin Irritation | ||
| (ISO 10993-10: 2010) | Not a primary skin irritant under | |
| the conditions of the study | Same | |
| Dermal sensitization | ||
| (ISO 10993-10: 2010) | Not a dermal sensitizer under the | |
| conditions of the study | Same |
| Table 5.2: Comparison of Physical, Biocompatibility and Performance Testing | ||
|---|---|---|
5.9 A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:
Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) meet requirements per ASTM D3577-09, ASTM D6124-06, ASTM D 5151-06, ASTM D5712-10 and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
6
A brief discussion of the clinical submitted, reference, or relied on in the 5.10 premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Substantial Equivalent Conclusions 5.11
Based on the comparison of intended use, design, materials, and performance, our Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are substantial equivalent to its predicate devices.