(235 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a nitrile glove, with no mention of AI or ML technologies.
No.
The device, "Powder Free Nitrile Patient Examination Gloves," is intended for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is a glove, which is intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile, not software. The description details material properties and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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." This describes a barrier device used during physical examination or procedures.
- Device Description: The description focuses on the physical properties of the glove (nitrile film, barrier to body fluids, tensile properties) and its manufacturing standards (ASTM D6319, ASTM D5151).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on the physical integrity and barrier properties of the glove, not on the analysis of biological samples.
Therefore, based on the provided information, this device is a medical device used for barrier protection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves, Blue 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)
LZA
Device Description
- How the device functions: Nitrile films form a barrier to body fluids and bloodborne Pathogens
- Scientific concepts that form the basis for the device: The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
- Physical and performance characteristics such as design, materials and physical properties: Nitrile 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 glove is manufactured in accordance with the requirements of ASTM D6319 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)
Non-clinical bench testing was conducted to demonstrate equivalence to the predicate device. The following tests were performed:
- Dimension per ASTM D6319-10
- Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10
- Water leak test on pinhole per ASTM D6319-10 and per 21 CFR 800.20
- Powder Residual tests per ASTM D6319-10(Reapproved 2011)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01 (Primary Skin Irritation in rabbits, Dermal sensitization in the guinea pig)
Key Results:
- Dimensions: Length ≥230mm (device range 234-243mm), Width (Small 70-90mm, Medium 85-105mm, Large 100-120mm, X Large 110-130mm; device ranges 78-85mm, 95-99mm, 108-113mm, 117-126mm respectively), Thickness (Fingertip ≥0.05mm, Palm ≥0.05mm; device ranges 0.08-0.11mm, 0.08-0.12mm respectively). All within ASTM standard.
- Physical Properties: Tensile strength (Before aging 20-23MPa, After aging 18-21MPa; standard ≥14MPa). Elongated rate (Before aging 560-600%, After aging 530-580%; standard ≥400%, ≥500% before aging). All within ASTM standard.
- Freedom from pinholes: Passed Standard Acceptance Criteria per 21 CFR 800.20 and ASTM D6319-10, tested in accordance with ASTM D5151-06 (Reapproved 2011).
- Powder Residual: 0.1mg/glove, meeting ASTM D6319-10 (Test method D6124-06).
- Biocompatibility: Under the conditions of the study, the device was a non-irritant and a non-sensitizer per ISO 10993-10: 2010-08-01.
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
Image /page/0/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" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Suqian Xingye Glove Co., Ltd. c/o Mr. Chu Xiaoan Beijing Easylink Co., Ltd. Room F302 Bldg. 41. Jing Cheng Ya Ju Courtyard 6 of Southern Dou Ge Zhuang Beijing 100121 CHINA
Re: K151680
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 3, 2016 Received: January 11, 2016
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.
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
1
Part 807); labeling (21 CFR Part 801 and Part 809); medical device 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 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin 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) K151680
Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Color
Indications for Use (Describe)
Powder Free Nitrile Patient Examination Gloves, Blue 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 6 510(k) Summary
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: K 151680
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Suqian Xingye Glove Co,Ltd |
|---|---|
| Submitter's address : | Dongwu Road,Economic Development |
| Zone,Suqian City,Jiangsu | |
| Province,223800,China | |
| Phone number : | 0086-527-82860533 |
| Fax number : | 0086-527-82860080 |
| Name of contact person: | Jian Zhong Deng |
| Date of preparation : | 2015-11-07 |
2.0 Name of the Device
| Device Name: | Powder Free Nitrile Patient Examination
Gloves, Blue Color |
|-------------------------|---------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination
Gloves, Blue Color |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
3.0 Predicate device
| Device Name: | Nitrile Powder Free Patient Examination
Gloves, Cloured (Blue) |
|----------------|-------------------------------------------------------------------|
| Company name: | Tangshan Zhonghong Pulin Plastic Co.,Ltd. |
| 510(K) Number: | K120970 |
4.0 Device Description:
- 4.1 How the device functions: Nitrile films form a barrier to body fluids and bloodborne Pathogens
4.2 Scientific concepts that form the basis for the device
4
The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
Physical and performance characteristics such as design, 4.3 materials and physical properties:
Nitrile 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 glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
5.0 Device Intended Use (Indication for use):
Powder Free Nitrile Patient Examination Gloves, Blue 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 Nitrile Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance | |
|---|---|---|---|
| Dimension | ASTM standard D 6319-10. | ||
| Length | ≥230mm | 234-243mm | |
| Width | Small 70-90 mm | 78-85mm | |
| Medium 85-105mm | 95-99mm | ||
| Large 100-120mm | 108-113mm | ||
| X large 110-130 mm | 117-126mm | ||
| Thickness | Fingertip ≥0.05mm | 0.08-0.11 mm | |
| Palm ≥0.05mm | 0.08-0.12 mm | ||
| Physical | |||
| Properties | ASTM standard D 6319-10. | ||
| Tensile strength | |||
| (Before aging) | 20-23MPa | ||
| Tensile strength | |||
| (After aging) | ≥14MPa | 18-21 MPa | |
| Elongated rate | |||
| (Before aging) | ≥500% | 560-600% | |
| Elongated rate | |||
| (After aging) | ≥400% | 530-580% | |
| Freedom from | |||
| pinholes | • 21 CFR 800.20 | Passed Standard | |
| Acceptance Criteria | |||
| • ASTM standard D 6319-10. | |||
| Test method in accordance with | |||
| ASTM D5151-06(Reapproved 2011) | |||
| Powder Residual | ASTM standard D 6319-10. | 0.1mg/glove | |
| Test method in accordance with | |||
| D6124-06(Reaffirmation 2011) | |||
| Biocompatibility | Primary Skin Irritation in rabbits | Under the conditions | |
| of the study, the | |||
| device was a | |||
| non-irritant. | |||
| ISO 10993-10: Third Edition | |||
| 2010-08-01 | |||
| Dermal sensitization in the guinea pig | Under the conditions | ||
| of the study, the | |||
| device was a | |||
| non-sensitizer | |||
| ISO 10993-10: Third Edition | |||
| 2010-08-01 |
5
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Powder Free Nitrile Patient Examination Gloves, Blue Color made by Sugian Xingye Glove Co,Ltd met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- . Dimension per ASTM D6319-10,
- Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ . After aging) per ASTM D6319-10,
- Water leak test on pinhole per ASTM D6319-10 and per 21 CFR 800.20, ●
- . Powder Residual tests per ASTM D6319-10(Reapproved 2011)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
Substantial Equivalent Based on Assessment of Clinical Performance Data: 8.0 -
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
So determination of substantial equivalence is not based on an assessment of clinical performance data.
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Tangshan Zhonghong | ||
| Pulin Plastic Co., Ltd. | Suqian Xingye Glove | ||
| Co,Ltd | -- | ||
| 510(K) | |||
| Number | K120970 | K151680 | |
| Product name | Nitrile Powder Free | ||
| Patient Examination | |||
| Gloves, Cloured (Blue) | Powder Free Nitrile | ||
| Patient Examination | |||
| Gloves, Blue Color | same | ||
| Product Code | LZA | LZA | same |
| Size | Small/ Medium/ | ||
| Large/X large | Small/ Medium/ | ||
| Large/X large | same | ||
| Intend for use | Nitrile Powder Free | ||
| Patient Examination | |||
| Gloves, Cloured (Blue) 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. | Powder Free Nitrile | ||
| Patient Examination | |||
| Gloves, 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. | Substantially | ||
| equivalent | |||
| Device Description | |||
| and | |||
| Specifications | Meets ASTM D6319-10 | Meets ASTM | |
| D6319-10 | Substantially | ||
| equivalent |
9.0 Substantial Equivalence Comparison:
6
| Dimensions | | Meets ASTM
D6319-10 | 234 mm min for all
sizes | Substantially
equivalent | | |
|-------------------------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------|---------|--|
| Dimensions
--Length | | ≥230mm min | | | | |
| Dimensions
-- Width | | Meets ASTM D6319-10 | | Substantially
equivalent | | |
| | Small | 70-90 mm | Small 78-85 mm | | | |
| | Medium | 85-105mm | Medium 95-99 mm | | | |
| | Large | 100-120mm | Large 108-113mm | | | |
| | X large | 110-130 mm | X large 117-126 mm | | | |
| Dimensions
--Thickness | | Meets ASTM D6319-10 | | Substantially
equivalent | | |
| | | Finger 0.05mm min.
Palm 0.05mm min. | Thickness (mm) min.
Finger 0.08
Palm 0.08 | | | |
| Physical
Properties | | Meets ASTM D D6319-10 | Aging Before After | Substantially
equivalent | | |
| | | Before aging/after aging
Elongation ≥500%
Tensile Strength≥ 14MPa | Elongation
(%) | 560-600 | 530-580 | |
| | | | Tensile
Strength
(MPa) | 20-23 | 18-21 | |
| Freedom from
Pinholes | | Meets
• 21 CFR 800.20
• ASTM D6319-10 | Meets
• 21 CFR 800.20
• ASTM D6319-10 | Substantially
equivalent | | |
| | | Test method in accordance
with ASTM D5151-06
(Reapproved 2011) | Tested in accordance
with ASTM D5151
(Reapproved 2011)
with acceptable results | | | |
| Residual
Powder | | Meets ASTM
D 6124-06
(Reapproved 2011) | Meets ASTM
D 6124-06
(Reapproved 2011) | Substantially
equivalent | | |
| | | below 2mg of residual
powder | Results generated
values below 2mg of
residual powder | | | |
| Materials used
to fabricate the
devices | | Nitrile | Nitrile | Substantially
equivalent | | |
| Dusting or
Donning
Powder: | | PU | PU-120C | Substantially
equivalent | | |
| Dusting or
Donning
Powder: name | | Surface Coating Agent | Surface Coating Agent | Substantially
equivalent | | |
| Compare
performance
data supporting
substantial
equivalence | | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D6319-10
ASTM D6124-06
(Reapproved 2011) | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D6319-10
ASTM D6124-06
(Reapproved 2011) | Substantially
equivalent | | |
| Single Patient
Use | | Single Patient Use | Single Patient Use | Substantially
equivalent | | |
| Biocompatibility | | Under the conditions of this
study, the test article was a
non- irritant or non-
sensitizer | Under the conditions of
this study, the test
article was a non-
irritant or non- | Substantially
equivalent | | |
7
| sensitizer. | |||
|---|---|---|---|
| SKIN IRRITATION | |||
| DERMAL and | SKIN IRRITATION | ||
| SENSITIZATION | DERMAL | ||
| and | |||
| STUDIES Meets ISO | SENSITIZATION | ||
| 10993-10:2002/Amd.1:2006 | STUDIES Meets ISO | ||
| 10993-10: Third | |||
| Edition 2010-08-01. | |||
| Labeling for | -Powder Free | -Powder Free | Substantially |
| the legally | -Patient Examination | -Patient Examination | equivalent |
| marketed | Glove | Glove | |
| device to | -Single Use Only | -Single Use Only | |
| which | - Manufactured For: | - Manufactured For: | |
| substantial | - Lot | - Lot | |
| equivalence is | -Blue color | -Blue color | |
| claimed. | - Non sterile | - Non sterile |
10.0 Conclusion:
It can be concluded that the Powder Free Nitrile Patient Examination Gloves, Blue Color is as safe, as effective, and performs as well as the predicate device, Nitrile Powder Free Patient Examination Gloves, Cloured (Blue), Tangshan Zhonghong Pulin Plastic Co., Ltd., K120970.
The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the predicate device.