(159 days)
Not Found
No
The device is a simple physical barrier (gloves) and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is described as a glove intended to prevent contamination between patient and examiner, acting as a barrier to body fluids and bloodborne pathogens. It does not treat or cure any medical condition.
No
Explanation: The device, Powder Free Vinyl Patient Examination Gloves, is described as a non-sterile disposable device intended for medical purposes worn to prevent contamination. Its function is to create a barrier, not to diagnose conditions or processes.
No
The device is a physical glove made of PVC, designed to be worn on the hand or finger. The description focuses on material properties and physical performance standards (ASTM, ISO, 21 CFR), not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the glove (PVC film, barrier to body fluids, tensile properties) and its manufacturing standards (ASTM). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Any of the typical performance metrics associated with IVDs (sensitivity, specificity, etc.)
The device is a medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (viny) chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
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)
The device meets performance characteristics compared to ASTM or equivalent standards for: Dimension, Physical Properties, Freedom from pinholes, Powder Residual, and Biocompatibility (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig). Key results indicate that the device "Meets" all specified standards and "Passes" biocompatibility tests (Not a Primary Skin Irritant, Not a Dermal Sensitizer). Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
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
§ 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
510(K) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
Premarket Notification [510(k)] Summary
NOV 2 6 2013
- 1.0 Submitter:
| Submitter's name : | Jiangsu Handsafe Glove Co., Ltd. |
|---|---|
| Submitter's address : | Century Road, The Economic Development |
| Zone, Suqian, Jiangsu, 223800 China | |
| Phone number : | 86-527-88286058 |
| Fax number : | 86-527-88286058 |
| Name of contact person: | Ms.Sha Sophia |
| Date of preparation : | 2013-11-21 |
Name of the Device 2.0
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Light Yellow Color |
|-------------------------|---------------------------------------------------------------------|
| Proprietary/Trade name: | Handsafe |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove
Light Yellow Color |
|----------------|-------------------------------------------------------------------|
| Company name: | PPP Medical and Safety Products Limited |
| 510(K) Number: | K110972. |
4.0 Device Description:
How the device functions: 4.1 PVC films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a
1
medical procedure.
4.3 Physical and performance characteristics such as design, materials and physical properties:
Poly (viny) chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Vinyl Patient Examination Gloves, Light Yellow Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D | |
| 5250-06(Reapproved 2011). | Meets | |
| Physical Properties | ASTM standard D | |
| 5250-06(Reapproved 2011). | Meets | |
| Freedom from | ||
| pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 | |
| (Reapproved 2011).and | ||
| D6124-06(Reapproved 2011). | Meets | |
| 230mm min | ASTM D5250 | 230mm min for all sizes |
| equivalent | ||
| Dimensions | ASTM D5250 | |
| equivalent | ||
| -- Width | Meets ASTM | |
| D5250-06 | ||
| (Reapproved 2011) | ||
| Small 80-90 mm | ||
| Medium 90-100mm | ||
| Large 100-110mm | ||
| Xlarge 110-120 mm | Small 80-85 mm | |
| Medium 95-97 mm | ||
| Large 102-108mm | ||
| X large 114-118 mm | ||
| Dimensions | ||
| --Thickness | Meets ASTM | |
| D5250-06 | ||
| (Reapproved 2011) | ||
| equivalent | ||
| Finger 0.05mm min. | ||
| Palm 0.08mm min. | Thickness (mm) min. | |
| Finger 0.09-0.12 | ||
| Palm 0.09-0.12 | ||
| Physical | ||
| Properties | Meets ASTM D | |
| 5250-06 | ||
| (Reapproved 2011) | ASTM D5250 | |
| equivalent | ||
| Before aging/after aging | ||
| Elongation ≥300% | ||
| Tensile Strength≥ 14MPa | Before aging/after aging | |
| Elongation :330-420% | ||
| Tensile Strength:15-18 MPa | ||
| Freedom from | ||
| Pinholes | Meets | |
| • 21 CFR 800.20 | ||
| • ASTM D5250-06 | ||
| (Reapproved 2011) | ||
| • ASTM D 5151-06 | ||
| (Reapproved 2011) | 21 CFR 800.20 | |
| ASTM D5250 | ||
| ASTM D 5151 | Meets ASTM | |
| D5151-06 | ||
| (Reapproved 2011) | ||
| Holes at | ||
| Inspection Level 1 | ||
| AQL2.5 | Substantially | |
| equivalent | ||
| Residual | ||
| Powder | Meets ASTM | |
| D 6124-06 | ||
| (Reapproved 2011) | ||
| below 2mg of residual | ||
| powder | ASTM D 6124 | Meets ASTM |
| D 6124-06 | ||
| (Reapproved 2011) | ||
| Results generated values | ||
| below 2mg of residual | ||
| powder | Substantially | |
| equivalent | ||
| Materials used | ||
| to fabricate the | ||
| devices | PVC | If the glove is made |
| of a polymer or other | ||
| type of material. | ||
| identify the material. | PVC | Substantially |
| equivalent | ||
| Dusting or | ||
| Donning | ||
| Powder: | PU | If a donning lubricant |
| is used, state the | ||
| composition | ||
| and include | ||
| biocompatibility data | ||
| for the lubricant in an | ||
| identified attachment; | ||
| also state the name, | ||
| manufacturer, and | ||
| address below | PU | Substantially |
| equivalent | ||
| Dusting or | ||
| Donning | ||
| Powder: name | PU | Lubricant |
| Generic Name/ | ||
| Lubricant | ||
| Brand Name | Surface Coating Agent | Substantially |
| equivalent | ||
| Compare | ||
| performance | ||
| data supporting | ||
| substantial | ||
| equivalence | Meets | |
| ASTM D5151-06 | ||
| (Reapproved 2011) | ||
| ASTM D5250-06 | ||
| (Reapproved 2011) | ||
| ASTM D6124-06 | At this time FDA | |
| recognizes the | ||
| following standards: | ||
| Patient Examination | ||
| Gloves(PVC)ASTM | ||
| D5151(Detection of | Meets | |
| ASTM D5151-06 | ||
| (Reapproved 2011) | ||
| ASTM D5250-06 | ||
| (Reapproved 2011) | ||
| ASTM D6124-06 | Substantially | |
| equivalent | ||
| (Reapproved 2011) | Holes in Medical | |
| Gloves)ASTM | ||
| D6124(Residual | ||
| Powder on Medical | ||
| Gloves)ASTM | ||
| D5250(Poly(vinyl | ||
| chloride) Gloves) | (Reapproved 2011) | |
| Single Patient Use | Single Patient Use | Single Patient Use |
| equivalent | ||
| Biocompatibility | SKIN IRRITATION | |
| DERMAL and | ||
| SENSITIZATION | ||
| STUDIES Meets ISO | ||
| 10993-10:2002/Amd.I: | ||
| 2006 | SKIN IRRITATION | |
| DERMAL and | ||
| SENSITIZATION | ||
| STUDIES | ||
| ISO 10993-10 | The test article was a | |
| non-irritant or | ||
| non-sensitizer. |
SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10:2002
/Amd.1:2006 | Substantially
equivalent | |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Patient Examination
Glove
-Single Use Only
-Manufactured For:
- Lot
-Yellow color - non sterile | Chapter 4 | -Powder Free
-Patient Examination
Glove
-Single Use Only
-Manufactured For: - Lot
-Yellow color - non sterile | Substantially
equivalent | |
9.0 Substantial Equivalence Comparison:
3
4
10.0 Substantial Equivalence Comparison:
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterieak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove, Light Yellow Color PPP Medical and Safety Products Limited. K110972.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an emblem featuring three stylized, curved shapes that resemble a person embracing another person.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Jiangsu Handsafe Glove Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606 Bldg 1 Jiangxiang Yuan #209 Bei Si Huan Zhong Road, Haidian District Beijing CHINA 100083
Re: K131828
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Light Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 21, 2013 Received: October 24, 2013
Dear Mr. Xiaoan:
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.
6
Page 2 - Mr. Xiaoan
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 guestions 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,
Image /page/6/Picture/8 description: The image contains the text "Erif Disith". The text is in a bold, sans-serif font. The letters are tightly spaced together, and the word appears to be a brand name or product name. The text is black and the background is white.
Erin Keith M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131828
Device Name
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes I owda 1100 villy. I and or finger to prevent contamination between patient and examiner.
இ Over-The-Counter Use (21 CFR 801 Subpart C)
[] Prescription Use (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR USE ONE ONE ONE FOR FOR THE FOR THE mence of Center for Devices and Rediological Health (CDRH) (Signature)
Image /page/7/Picture/13 description: The image shows the text "Elizabeth F. Claverie-S 2013.11.26 00.05'00'". The text is in black and is on a white background. The text is likely a date or a time stamp.
FORN FDA 3881 (9/13)
total (127) 413-6740 P PCC Dobliching Ber