(76 days)
Not Found
No
The device description and intended use clearly define a physical examination glove, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No.
The device (examination glove) is intended to prevent contamination between patient and examiner, acting as a barrier, not to treat or alleviate a disease or condition.
No
Explanation: The device is a vinyl examination glove intended to prevent contamination, not to diagnose a condition.
No
The device is a physical examination glove made of PVC resin and plasticizers, clearly indicating it is a hardware device and 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 a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- Device Description: The description reinforces this by stating it's a glove intended to be worn on the hand or finger "to provide a barrier against potentially infectious materials and other contaminants."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in vitro (outside the body) to analyze these specimens.
- Predicate Devices: The listed predicate devices are also "POWDER-FREE VINYL PATIENT EXAMINATION GLOVES," which are not IVDs.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder-free vinyl Examination glove, clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner.
Product codes
LYZ
Device Description
The Powder-free vinyl Examination glove, clear (Non-colored) is disposable device made PVC resin and plasticizers (DINP), Ca-Zn stabilizer, TXIB into film, coated with Polyurethane to facilitate donning and it intended to be worn on the hand of finger(s) for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
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's, medical purposes
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)
Testing is performed as per ASTM D5250-06 and 21 CFR 800.20, gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves. Primary Skin Irritation testing in the rabbit and delayed contact Sensitization testing in the guinea pig indicate no irritation or sensitization.
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.
0
Executive Summary of
FEB 1 9 2009
POWDER-FREE VINYL EXAMINATION GLOVES, CLEAR (NON-COLORED)
| Submitter's Name | Quantum Co., Ltd |
|---|---|
| Submitter's address | No. 2-3-18 Hua Sheng Yuan Park, Linzi, |
| Shandong 255410 China | |
| Submistter's Telphone Number | +86-533-7480087 |
| Submiter's Fax Number | +86-533-7480085 |
| Name of Contact Person | Lijuan Wang |
| Date of Preparation | November 20th, 2008 |
| Device Description | The Powder-free vinyl Examination |
| glove, clear (Non-colored) is disposable | |
| device made PVC resin and plasticizers | |
| (DINP), Ca-Zn stabilizer, TXIB into film, | |
| coated with Polyurethane to facilitate | |
| donning and it intended to be worn on | |
| the hand of finger(s) for medical purpose | |
| to provide a barrier against potentially | |
| infectious materials and other | |
| contaminants. | |
| Legally Marketed Device To Which | |
| Equivalency is Being Claimed | Powder-free vinyl Examination glove, |
| clear (Non-colored) is described in the | |
| 510 (k) notification are substantially | |
| equivalent to the Class I patient | |
| examination gloves, Vinyl, 80LYZ coated | |
| with Polyurethane dusting powder, that | |
| meets the current ASTM D5250-06 | |
| "Standard Specification for Polyvinyl | |
| Examination Gloves for Medical | |
| Application" | |
| Predicate Device | A) K070149 POWDER-FREE VINYL |
| PATIENT EXAMINATION GLOVES | |
| MANUFACTURED BY: WUXI | |
| SHENZHOU PLASTIC PRODUCTS | |
| CO., LTD. | |
| Predicate Device | B) K073193 POWDER-FREE VINYL |
| PATIENT EXAMINATION GLOVES | |
| MANUFACTURED BY: SHIJIAZHUANG | |
| PROSPEROUS PLASTIC CO., LTD. | |
| Summary of Technological | |
| Characteristics | |
| Compared | |
| to | |
| the | |
| Predicate Device | |
| Performance testing report | Technological characteristics. Gloves are |
| made from PVC and DINP compound | |
| and the initial products are powder free | |
| vinyl | |
| examination | |
| gloves, | |
| clear | |
| (non-colored). | |
| Intended use of the Device | A Powder-free vinyl Examination glove, |
| clear (Non-colored) 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. | |
| Brief Discussion of Nonclinical Tests | Testing is performed as per ASTM |
| D5250-06 and 21 CFR 800.20, gloves | |
| meet all the current Specifications listed | |
| under the ASTM D5250-06 Standard | |
| Specification for Vinyl | |
| Examination | |
| Gloves. | |
| Primary Skin Irritation testing in the | |
| rabbit and delayed contact Sensitization | |
| testing in the guinea pig indicate no | |
| irritation or sensitization. | |
| Brief Discussion of Clinical Tests | No new clinical tests were conducted |
| under this 510 (k) | |
| Conclusions Drawn for the Non clinical | |
| and Clinical Tests | Non-clinical Laboratory and animal data |
| indicate that the pre-powdered | |
| vinyl | |
| products meet all performance | |
| and | |
| biocompatibility requirements. | |
| Other Information Deemed Necessary by | |
| FDA | Non Applicable |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2009
Ms. Lijuan Wang Operation Manager Quantum Company, Limited Number 2-3-18 Hua Sheng Yuan Park Linzi Shandong 255410 CHINA
K083600 Re:
Trade/Device Name: Powder-Free Vinyl Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 1, 2009 Received: February 4, 2009
Dear Ms. Wang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Wang
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sinceraly yours,
Anthony D. Watson for
Ginette Y. Michaud, M.D.
Acting Director.
Division of Anesthesiology, General Hospital,
Infection Control and-Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
QUANTUM CO.,LTD. No. 2-3-18 Hua Sheng Yuan Park, Linzi, Shandong 255410 China Tel: +86-533-7480087 Fax: +86-533-7480085
Attachment
Indications for Use
510(k) Number (if known): _K083600
Device Name: _Powder-Free, Vinyl Examination Gloves, Clear (Non-Colored)
Indications for Use:
Powder-free vinyl Examination glove, clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between t patient and examiner. 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Yours faithfully
signature
Ms. Lijuan Wang Operation Manager Date: Jan 29, 2009
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuli A. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083606
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