(128 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No
The device is an examination glove, which is intended to prevent contamination, not to treat a condition or disease.
No
The device is a disposable examination glove intended to prevent contamination between patient and examiner. Its purpose is protective, not diagnostic.
No
The device is a physical examination glove made of nitrile rubber, clearly described as a disposable device worn on the hand or finger. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. 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 material (nitrile rubber), color, and compliance with standards related to physical properties and safety for examination gloves. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions
The device is clearly described as a patient examination glove, which is a medical device used for protection and hygiene, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Titan powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.
Product codes
LZA
Device Description
Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans), 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 6319-10 (Published 03/18/2011)
Physical Property: Meets ASTM D 6319-10 (Published 03/18/2011)
Free of Pinhole: Meets ASTM D5151 (AQL 2.5) (Published 08/20/2012)
Residue Powder: Meets ASTM D6124 (Published 08/20/2012)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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Section 5: 510k Summary
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
Submitter & Foreign Manufacture Identification 5.1
Hebei HongSen Plastics Technology Co., Ltd The Eastern Industrial Accumulation Area Nangong City, Xingtai City, Hebei Province, China Tel: 86-311-85656588 Submitter's FDA Registration Number: N/A
SEP 2 5 2013
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
Date of Summary: April 15, 2013 5.3
5.4 Device Name: Proprietary Name:
Common Name: Classification Name: Device Classification: Regulation Number: Panel: General Product Code:
Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans) Patient examination glove Patient examination glove I 21 CFR 880.6250 Hospital LZA
Predicate Device Information: ર્ડ
:
K121992, "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue (1) Color", manufactured by "Xinwei (Shandong) Plastic and Rubber Products Co., Ltd."
ર્સ્વર્સ Device description:
Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.
1
5.7 Intended Use:
The Titans powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.
5.8 Comparison to Predicate Devices
The powder free nitrile examination gloves, blue, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
K121992, "Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Blue (1) Color", manufactured by "Xinwei (Shandong) Plastic and Rubber Products Co., Ltd."
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Our Device | Predicate Device (K121992) |
|---|---|---|
| Indication for | ||
| Use | Disposable device intended for medical | |
| purposes that is worn on the examiner's hand | ||
| or finger to prevent contamination between | ||
| patient and examiner. It has blue color and is | ||
| sold as non sterile. | A patient examination glove is a | |
| disposable device intended for | ||
| medical purposes that is | ||
| worn upon the examiner's hands or | ||
| finger to prevent contamination | ||
| between patient and examiner | ||
| (2ICFR 880.6250) | ||
| Basic Design | A garment covering the hand and waist | |
| area. Gloves have separate sheaths or | ||
| openings for each finger and the thumb. | Same | |
| Materials | Nitrile rubber | Same |
| Size | XS, S, M, L, XL, XXL | S, M, L,XL |
| Single Use | Yes | Yes |
| Color | blue | Blue |
| Sterile | Non sterile | None 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.
2
Section 5: 510k Summary
The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans), 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 (K121992) |
|---|---|---|
| Dimension | Meets ASTM D 6319-10 | |
| (Published 03/18/2011) | Meets ASTM D 6319-10 | |
| (Publication date unknown) | ||
| Physical Property | Meets ASTM D 6319-10 | |
| (Published 03/18/2011) | Meets ASTM D 6319-10 | |
| (Publication date unknown) | ||
| Free of Pinhole | Meets ASTM D5151 (AQL | |
| 2.5) | ||
| (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) | ||
| 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 | |||
|---|---|---|---|
A brief discussion of the non-clinical testing data that was submitted, 5.9 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 Patient Examination Gloves, Blue Color (Brand Name: Titans) meet requirements per ASTM D6319-10, ASTM D6124-06, ASTM D 5151-06, and ISO 10993-10. It is safe and effective, and its performance meets the requirements of its predefined acceptance criteria and intended uses.
3
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 Patient Examination Gloves, Blue Color (Brand Name: Titans) are substantial equivalent to its predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2013
Hebei HongSen Plastics Technology Company Limited C/O Charles Shen Manton Business and Technology Services 5 Carey Street PENNINGTON NJ 08534 US
- Re: K131440
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color (Brand Name Titans) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 11, 2013 Received: July 1, 2013
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.
5
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/ResourcesforYou/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,
FDA Richard C.
Chapman
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
for
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131440
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue color (Brand Name: Titans)
Indications for Use (Describe)
The Titan powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
EF
PSC | | | shindang Services (301) | 443-6740
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NE ON MIN FOR THE FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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