(162 days)
Not Found
No
The device is a simple examination glove and the summary focuses on physical properties and material standards, with no mention of AI or ML.
No.
The device, Powder-Free Yellow Vinyl Patient Examination Gloves, is intended to prevent contamination between patient and examiner and does not actively treat or diagnose a disease or condition.
No
The device is a glove, which is described as being for "medical purposes" to "prevent contamination," not for diagnosing conditions.
No
The device is described as physical gloves made of vinyl, with performance metrics related to dimensions, thickness, physical properties, and freedom from pinholes, all of which are characteristics of a hardware device, not software.
No, 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 or finger to prevent contamination between patient and examiner." This is a barrier function for physical protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the gloves (ASTM D 5250-06). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical device, specifically a patient examination glove, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Powder-Free Yellow Vinyl Patient Examination Gloves 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
LYZ
Device Description
Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
Scientific concepts that form the basis for the device
The PVC 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:
PVC gloves are 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 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 (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)
Nonclinical studies were performed to demonstrate that the device meets requirements per ASTM Powder-Free Yellow D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01, specifically regarding freedom from pinholes, residual powder, and biocompatibility (skin irritation and sensitization). The results generated values below 2mg of residual powder. The test article for biocompatibility was found to be a non-irritant and non-sensitizer.
Clinical data was not needed for this device.
The conclusion is that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims, and perform as well as the predicate device.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
Xinfu Medical Products Co., Ltd. c/o Mr. Chu Xiaoan Room 1606 Bldg. 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian Dis Beijing 100083 CHINA
Re: K152719
Trade/Device Name: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 15, 2016 Received: January 19, 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 Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
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.
If vou 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152719
Device Name
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder-Free Yellow Vinyl Patient Examination Gloves 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section C
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
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Xinfu Medical Products Co.,Ltd. |
|---|---|
| Submitter's address : | East of Lipingtuo, Luannan County, Tangshan City, |
| 063502 Hebei Province ,China | |
| Phone number : | (86)315-4431166 |
| Fax number : | (86)315-4431333 |
| Name of contact person: | Xie Wenxing |
| Date the summary was prepared: | 2016-03-01 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder-Free Yellow Vinyl Patient Examination Gloves |
|---|---|
| Proprietary/Trade name: | "Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves" |
| Common Name: | Patient ex amination glove |
| Classification Name: | Patient ex amination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 80.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.
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[(a)(4)] A description of the device
Device Description: Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC 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:
PVC gloves are 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 D5250 and ASTM D5151 requirements.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder-Free Yellow Vinyl Patient Examination Gloves 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.
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device.
| Features & Description | Predicate Device | Subject Device | Result of Comparison |
|---|---|---|---|
| Company | Hebei Leader Plastic Co., Ltd. | Xinfu Medical Products Co.,Ltd. | -- |
| 510(K) Number | K122920 | K152719 | |
| Product name | Powder Free Vinyl Patient Examination Gloves. Colored (Yellow) | Powder-Free Yellow Vinyl Patient Examination Gloves | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large | Substantially equivalent |
| Intend for use | Powder Free Vinyl Patient Examination Gloves. Colored (Yellow) 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 Yellow Synthetic Vinyl Patient Examination Gloves 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 D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06 (Reapproved 2011) | Substantially equivalent |
| Dimensions -- Length | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250-06 (Reapproved 2011) | Substantially equivalent |
| ≥230mm min. | 230mm min for all sizes | ||
| Dimensions -- Width | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Small 80-90 mm | |||
| Medium 90-100mm | |||
| Large 100-110mm | |||
| X large 110-120 mm | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Small 85-88 mm | |||
| Medium 94-97 mm | |||
| Large 103-106mm | |||
| X large 113-115 mm | Substantially equivalent | ||
| Dimensions | |||
| -- Thickness | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | |||
| Finger 0.05mm min. | |||
| Palm 0.08mm min. | Finger 0.05mm min. | ||
| Palm 0.08mm min. | |||
| Physical Properties | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | Substantially | ||
| equivalent | |||
| Before aging/after aging | |||
| Elongation ≥300% | |||
| Tensile Strength≥14MPa | Before aging/after aging | ||
| Elongation ≥300% | |||
| Tensile Strength≥ 14MPa | |||
| Freedom from | |||
| Pinholes | Meets | ||
| • 21 CFR 800.20 | |||
| • ASTM D5250-06 | |||
| (Reapproved 2011) | |||
| • ASTM D 5151-06 | |||
| (Reapproved 2011) | Meets | ||
| • 21 CFR 800.20 | |||
| • ASTM D5250-06 | |||
| (Reapproved 2011) | |||
| • ASTM D 5151-06 | |||
| (Reapproved 2011) | |||
| Holes | |||
| Inspection Level I | |||
| AQL2.5 | Substantially | ||
| equivalent | |||
| Residual Powder | Meets ASTM | ||
| D6124-06 | |||
| (Reaffirmation |
-
| ASTM D6124-06
(Reaffirmation 2011)
Results generated values
below 2mg of residual powder | Substantially
equivalent |
| Compare all
materials used to
fabricate the
devices | PVC | PVC | Substantially
equivalent |
| Dusting or
Donning Powder: | PU | PU | Substantially
equivalent |
| Dusting or
Donning Powder:
name | PU | Polyurethane | Substantially
equivalent |
| Compare
performance data
supporting
substantial
equivalence | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 2011) | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 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 and
non-sensitizer.
SKIN IRRITATION DERMAL
and SENSITIZATION
STUDIES Meets ISO
10993-10:2002/Amd.1:2006 | Under the conditions of
this study, the test article
was a non-irritant and
non-sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION STUDIES
Meets ISO 10993-10 Third
Edition 2010-08-01 | Substantially
equivalent |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed. | -Powder Free
-Devices color: Yellow
-Patient Examination Glove
-Non sterile
-Single Use Only
- Manufactured For:
- Lot | -Powder Free
-Devices color: Yellow
-Patient Examination Glove
-Non sterile
-Single Use Only - Manufactured For:
- Lot | Substantially
equivalent |
The Powder-Free Yellow Vinyl Patient Examination Gloves non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
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[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Vinyl Patient Examination Glovesmeet requirements per ASTM Powder-Free Yellow D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.
[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. [(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well as the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and the Powder-Free Yellow Vinyl Patient Examination Gloves is as effective, and performs as well as the predicate device Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920.