(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML technologies.
No
The device is a glove intended to prevent contamination, not to treat a medical condition or disease.
No
The device is described as a glove intended to prevent contamination between a patient and examiner, acting as a barrier, not to diagnose a condition.
No
The device is a physical glove made of nitrile, not software. The description focuses on material properties and physical barrier function.
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 the 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 body.
- Device Description: The description focuses on the physical properties of the nitrile material as a barrier. It does not mention any reagents, assays, or analysis of biological samples, which are characteristic of IVDs.
- Lack of IVD-related terms: The document does not contain any terms typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.
- Performance Studies: The performance studies listed are bench tests related to the physical properties and barrier function of the glove (dimension, tensile strength, water leak, etc.). These are not studies evaluating the accuracy or performance of a diagnostic test.
Therefore, the Xingyu Powder Free Nitrile Patient Examination Gloves are a medical device intended for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Xingyu Powder Free Nitrile Patient Examination Gloves, White 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 the patient and examiner
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitrile films form a barrier to prevent contamination between patient and examiner. 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. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger of the examiner
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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,White Color made by Shandong Xingyu Gloves 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(Reapproved 2015),
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10(Reapproved 2015),
- . Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20,
- . Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
Cilnical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
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
July 31, 2017
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shandong Xingyu Gloves Co., Ltd % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41. Jing Cheng Ya Ju. Courtyard 6 of Southern Dou Ge Zhuang, Beijing, 100121, China
Re: K171615
Trade/Device Name: Xingyu Nitrile Powder Free Patient Examination Gloves, White color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 9, 2017 Received: July 19, 2017
Dear Chu 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
1
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 devicerelated 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 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,
Mark S. Fellman -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Xingyu Powder Free Nitrile Patient Examination Gloves, White Color
Indications for Use (Describe)
Xingyu Powder Free Nittile Patient Examination Gloves, White 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 the 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
510(K) Summary
"The assigned 510(k) number is: K171615 "
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name : | Shandong Xingyu Gloves Co.,Ltd |
|---|---|
| Submitter's address : | No.2158, Yaoqian Road,Economic |
| Development Zone, Gaomi | |
| City,Shandong,261502,China | |
| Phone number : | 0086-536-2588123 |
| Fax number : | 0086-536-2586328 |
| Name of contact person: | Xu Qiang |
| Date of preparation : | 2017-07-07 |
2.0 Name of the Device
| Device Name: | Powder Free Nitrile Patient Examination
Gloves,White Color |
|-------------------------|----------------------------------------------------------------------|
| Proprietary/Trade name: | Xingyu Powder Free Nitrile Patient
Examination Gloves,White 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: | Powder Free Nitrile Patient Examination
Gloves, White Color |
|----------------|----------------------------------------------------------------|
| Company name: | JiangSu DongLing Plastic & Rubber Co., Ltd. |
| 510(K) Number: | K110248 |
4.0 Device Description:
4.1 How the device functions:
Nitrile films form a barrier to prevent contamination between patient and examiner.
4.2 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.
4
4.3 Physical and performance characteristics such as design, materials and physical properties:
The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
5.0 Indication for use:
Xingyu Powder Free Nitrile Patient Examination Gloves, White 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:
Xingyu Powder Free Nitrile Patient Examination Gloves,White Color, non-sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | |
|---|---|---|
| Dimension | ASTM standard D 6319-10(Reapproved 2015) | |
| Length | ≥230mm | |
| Width | Small 70-90 mm | |
| Medium 85-105mm | ||
| Large 100-120mm | ||
| X large 110-130 mm | ||
| Thickness | Fingertip ≥0.05mm | |
| Palm ≥0.05mm | ||
| Physical | ||
| Properties | ASTM standard D 6319-10(Reapproved 2015) | |
| Tensile strength(Before aging) | ≥14MPa | |
| Tensile strength(After aging) | ||
| Elongated rate(Before aging) ≥500% | ||
| Elongated rate(After aging) ≥400% | ||
| Freedom from | ||
| pinholes | • 21 CFR 800.20 | |
| • ASTM standard D | ||
| 6319-10(Reapproved 2015). | ||
| Test method in accordance with | ||
| ASTM D5151-06(Reapproved 2015) | Passed Standard | |
| Acceptance Criteria | ||
| Powder Residual | ASTM standard D | |
| 6319-10(Reapproved 2015) | ||
| Test method in accordance with | ||
| D6124-06(Reaffirmation 2011) | Meets | |
| 0.1mg/glove | ||
| Biocompatibility | Primary Skin Irritation in rabbits | Passes |
| ISO 10993-10: Third Edition | ||
| 2010-08-01 | Not a Primary Skin | |
| Irritation | ||
| Dermal sensitization in the guinea | ||
| pig ISO 10993-10: Third Edition | ||
| 2010-08-01 | Passes | |
| Not a Primary Skin | ||
| Irritation |
7.1 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,White Color made by Shandong
5
Xingyu Gloves 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(Reapproved 2015),
- . Tensile strength (Before aging/ After aging) and Elongated rate (Before aging/ After aging) per ASTM D6319-10(Reapproved 2015),
- . Water leak test on pinhole per ASTM D6319-10(Reapproved 2015) and per 21 CFR 800.20,
- . Powder Residual tests per ASTM D6319-10(Reapproved 2015)
- Biocompatibility test per ISO 10993-10: Third Edition 2010-08-01.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data:
Clinical data was not needed to demonstrate that the subject glove is substantially equivalent to the predicate glove. So determination of substantial equivalence is not based on an assessment of clinical performance data.
| Features
& | Predicate Device | | Subject Device | | Result
of |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------|------------------------|--------------|
| Description | | | | | Comparison |
| Company | | JiangSu DongLing Plastic | | Shandong Xingyu Gloves | -- |
| | & Rubber Co., Ltd. | | Co.,Ltd | | |
| 510(K) Number | K110248 | | K171615 | | |
| Product name | | Powder Free Nitrile Patient | | Powder Free Nitrile | Same |
| | | Examination Gloves, White | Patient Examination | | |
| | Color | | | Gloves, White Color | |
| Product Code | LZA | | LZA | | Same |
| | | | | | |
| Size | Small/ Medium/ | | Small/ Medium/ | | Same |
| | Large/X large | | Large/X large | | |
| Intended use | | Powder Free Nitrile Patient | Powder | Free
Nitrile | Same |
| | | Examination Gloves, White | Patient | Examination | |
| | | Color is a disposable device | Gloves,White Color is a | | |
| | intended for medical | | device
disposable | | |
| | purposes that is worn on the | | intended | for medical | |
| | examiner's hand or finger to | | purposes that is worn on | | |
| | prevent contamination | | the examiner's hand or | | |
| | between patient and | | finger
prevent
to | | |
| | examiner. | | contamination
between | | |
| | | | patient and examiner. | | |
| Device | Meets ASTM D6319-10 | | Meets ASTM | | Same |
| Description and | | | D6319-10(Reapproved | | |
| Specifications | | | 2015) | | |
| Dimensions | Meets ASTM | | 232 mm min for all sizes | | Same |
| --Length | D6319-10 | | | | |
| ILS-2 | ≥230mm min | | | | |
| AQL4.0 | | | | | |
| Dimensions | Meets ASTM D6319-10 | | | | Same |
| -- Width | Small | 70-90 mm | Small | 80-88 mm | |
| ILS-2 | Medium | 85-105mm | Medium | 89-102 mm | |
| AQL4.0 | Large | 100-120mm | Large | 104-118mm | |
| | X large | 110-130 mm | X large | 115-129 mm | |
| Dimensions
--Thickness | Meets ASTM D6319-10 | | | | Same |
| IL S-2
AQL4.0 | 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 | Same |
| IL S-2
AQL4.0 | Before aging/after aging
Tensile Strength≥ 14MPa | Elongation
(%) | 560-600 | 460-560 | |
| | Before aging
Elongation ≥500%
After aging
Elongation ≥400% | | 18-25 | 17-21 | |
| | | Tensile
Strength
(MPa) | | | |
| Freedom from
Pinholes | Meets
• 21 CFR 800.20
• ASTM D6319-10 | Meets
• 21 CFR 800.20
• ASTM D
6319-10(Reapproved
2015) | | | Same |
| Inspection
Level I AQL2.5 | Test method in accordance
with ASTM D5151-06
(Reapproved 2015) | Tested in accordance
with ASTM D5151
(Reapproved 2015)
with acceptable results | | | |
| Residual
Powder | Meets ASTM
D 6124-06
(Reaffirmation 2011) | Meets ASTM
D 6124-06
(Reaffirmation 2011) | | | Same |
| | below 2mg of residual
powder | Results generated values
below 2mg of residual
powder | | | |
| Materials used
to fabricate the
devices | Nitrile | Nitrile | | | Same |
| Dusting or
Donning
Powder: name | Surface Coating Agent | Surface Coating Agent | | | Same |
| Standards | Meets
ASTM D5151-06
(Reapproved 2015)
ASTM D6319-10
ASTM D6124-06
(Reaffirmation 2011) | Meets
ASTM D5151-06
(Reapproved 2015)
ASTM D6319-10
ASTM D6124-06
(Reaffirmation 2011) | | | Same |
| Single Patient
Use | Single Patient Use | Single Patient Use | | | Same |
9.0 Substantial Equivalence Comparison:
6
7
| Biocompatibility | Under the conditions of this study, the test article
was a non- irritant or non-
sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10:2002/Amd.1:20
06 | Under the conditions of this study, the test
article was a non-
irritant or non-
sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10: Third Edition
2010-08-01. | Same |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Labeling | -Powder Free
-Patient Examination Glove
-Single Use Only
- Manufactured For:
- Lot
-White color
-Non sterile | -Powder Free
-Patient
Examination Glove
-Single Use Only - Manufactured For:
- Lot
-White color
-Non sterile | Same |
10.0 Conclusion:
Based on the nonclinical tests data, it can be concluded that the Xingyu Powder Free Nitrile Patient Examination Gloves,White Color is as safe, as effective, and performs as well as the predicate device, Powder Free Nitrile Patient Examination Gloves, White Color, JiangSu DongLing Plastic & Rubber Co., Ltd., K110248.