(100 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment to a patient.
No
The device is described as "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner," which indicates it is a barrier device, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor any condition.
No
The device is a physical examination glove, not a software application. The description focuses on material specifications and performance testing related to the physical properties of the glove.
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 gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D6319-10), which are relevant to their barrier function and safety for medical use, not for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
- Regulatory Context: The testing performed (ASTM D6319-10 and 21 CFR 800.20) and the predicate device (K103734) are consistent with medical gloves, which are regulated as medical devices, but not specifically as IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description does not align with the function of examination gloves.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
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
examiner's hand
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
Non-Clinical Performance Data: Testing performed per ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-10. Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
Clinical Data: No clinical data was required.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image shows a logo with a geometric design above the word "ENCOM". The geometric design is composed of four arrow-like shapes arranged in a circular pattern, resembling a stylized cross or plus sign. The word "ENCOM" is printed in a simple, sans-serif font, with the letters slightly spaced apart.
SECTION 5
510(k) Summary
Date Prepared: 21ª Mar 2012
POWDER FREE NITRILE EXAMINATION GLOVE
| 5.1 | Submitter's Name: | Encompass Medical Supplies Inc Limited |
|---|---|---|
| 5.2 | Submitter's Address: | Hua Shen Road, Wai Gao Qiao Free Trade Zone, |
| Shanghai 200131. | ||
| 5.3 | Contact No: | Tel: 0086-21-58666680 Fax: 0086-21-58666690 |
| 5.4 | Contact Person: | Mr. CJ Ang |
| Tel: +60-19-5125422 | ||
| 5.5 | Name of Device: | Powder Free Nitrile Examination Glove, Non |
| Sterile (Blue Colored, Black Colored and White | ||
| Colored) | ||
| Proprietary/Trade Name: | I) Powder Free Nitrile Examination Glove | |
| II) Other clients trade name and private labeling | ||
| Common Name: | ||
| Classification Name: | ||
| Device Classification: | ||
| Product Code: | Nitrile Examination Glove | |
| Patient Examination Glove (21 CER 880.6250) | ||
| Class I | ||
| LZA | ||
| 5.6 | Predicate device: | Powder Free Nitrile Examination Gloves, White |
ldentification of The Legally Marketed Device: 5.7
The Powder Free Colored Nitrile Examination Glove Class I patient examination gloves, Nitrile-80 LZA, meets all of the requirements of ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
Colored (K103734)
5.8 Description of Device:
The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.
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Image /page/1/Picture/0 description: The image shows a black and white symbol that resembles a stylized cross or a four-pointed star. Each arm of the cross is formed by a thick, angular shape, and the overall design has a somewhat rough or textured appearance, possibly due to the image's quality or the symbol's original creation method. The symbol is centrally positioned and stands out against the white background. The symbol is symmetrical.
ENCOME ...
Intended Use of the Device: 5.9
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 5.10
The technological characteristics of Powder Free Nitrile Examination Glove (Blue Colored, Blacked Colored and White Colored) are summarized below as compared to ASTM requirements and to the predicate devices (K103734):
| Characteristic | Device Performance | Predicate Devices |
|---|---|---|
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Physical Properties | Meets ASTM D0412-98 | Meets ASTM D0412-98 |
| Freedom From pin-holes | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Powder Free Residue | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Biocompatibility | ||
| Dermal Sensitization | Passed - | |
| Not a Dermal Sensitization | ||
| (ASTM F720-81 (Reapproved 2007)) | Passed - | |
| Not a Dermal Sensitization | ||
| (ASTM F720-81 (Reapproved 2007)) | ||
| Primary Skin Irritation | Passed - Not a Skin Irritant | |
| (Consumer product safety Commission, | ||
| Title 16, Chapter II, Part 1500) | Passed - Not a Skin Irritant | |
| (Consumer product safety Commission, | ||
| Title 16, Chapter II, Part 1500) |
Substantial Equivalent Based on Assessment of Non-Clinical 5.11 Performance Data
Testing performed per ASTM D6319-10 Standard Specification for Nitrile Examination Cloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-10.
Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization.
There are no special labeling claims and we do not claim our gloves to be hypoallergenic.
- Clinical Data: No clinical data was required. 5.12
5.13 Conclusion:
It can be concluded that the Powder Free Nitrite Examination Glove, Non Sterile (Blue Colored, Blacked Colored and White Colored) meet the ASTM standard or equivalent standard and FDA requirements.
Conclusively, we therefore claim that this device is substantially equivalent to its predicate device.
p. 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be three overlapping lines, possibly representing a stylized human form or a symbol related to health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. CJ Ang Encompass Medical Supplies Inc Limited Hua Shen Road Wai Gao Oiao Free Zone Shanghai, China 200131
MAY - 2 2012
Re: K120184
Trade/Device Name: Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: April 13, 2012 Received: April 19, 2012
Dear Mr. Ang:
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- Mr. Ang
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. Mataur
Anthony D. Watson, B.S., M.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
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Image /page/4/Picture/0 description: The image shows a logo with a geometric shape resembling a stylized plus sign or cross, formed by four arrow-like figures pointing inward. Below the logo, the text "ENCOM" is partially visible, with some letters cut off, suggesting it is the name associated with the logo. The overall impression is of a corporate or technological brand identity.
SECTION 3 INDICATION FOR USE STATEMENT
INDICATIONS FOR USE 3.1
K120184 510(k) Number (if known): ___
Powder Free Nitrile Examination Gloves, Non Sterile (Blue Device Name: Colored, Black Colored and White Colored).
Indications For Use:
The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Over-The-Counter Use × AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clarence-Willis
(Division Sign-Off) (Division Sign Siti)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
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210(k) Number: _______________________________________________________________________________________________________________________________________________________________