(247 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a vinyl glove, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, acting as a barrier rather than providing any therapeutic benefit or treatment for a disease or condition.
No
Explanation: The device is described as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." Its function is to act as a barrier to prevent contamination, not to diagnose any condition.
No
The device description clearly states it is a physical glove made of PVC film, intended to be worn on the hand or finger. It describes physical properties and manufacturing standards for a tangible product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device's intended use: The intended use of these gloves is to prevent contamination between the patient and the examiner by acting as a physical barrier worn on the hand. This is a protective barrier function, not a diagnostic test performed on a specimen.
- Lack of diagnostic function: The description and performance studies focus on the physical properties of the glove (barrier, tensile strength, biocompatibility) and its ability to prevent contamination. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the provided information, this device is a medical device used for protection and hygiene, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
PVC films form a barrier to prevent contamination between patient and examiner. 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. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
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 tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
- Dimension: ASTM D 5250-06(Reapproved 2011) for Length, Width, Thickness, Physical Properties.
- Powder Residual: ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 12, 2019
Jiangxi Jaysun Medcare 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, 100021 Cn
Re: K182575
Trade/Device Name: Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 11, 2019 Received: April 25, 2019
Dear Chu Xiaoan:
This letter corrects our substantially equivalent letter of May 24, 2019.
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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, 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.
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:___K182575
Premarket Notification [510(k)] Summary
Submitter: 1.0
| Submitter's name : | Jiangxi Jaysun Medcare Co.,Ltd. |
|---|---|
| Submitter's address : | No.1 Jaysun Road,Penghuwan Industrial Park |
| Pengze City, Jiujiang Jiangxi | |
| Province,332708,China | |
| Phone number : | 0086-0792- 5866108 |
| Fax number : | 0086-0792- 5866108 |
| Name of contact person: | Mr. Zong Run |
| Date of preparation: | 2019-05-15 |
2.0 Name of the Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|----------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder Free Vinyl Patient Examination Gloves,
Clear (non-colored) |
|----------------|----------------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663 |
4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner.
4.2 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.
4
Physical and performance characteristics such as design, materials and 4.3 physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 Technological Characteristics:
Shown below is a comparison of the technological characteristics of the subject device and the predicate device:
| Features & Description | Predicate Device
(K091663) | Subject Device
(K182575) | Result of
Comparison | | |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------|
| Company | Zhang Jia Gang
Fengyuan Plastic
Product Co. Ltd. | Jiangxi Jaysun
Medcare Co.,Ltd. | -- | | |
| 510(K) Number | K091663 | K182575 | -- | | |
| Product name | Powder Free Vinyl
Patient Examination
Gloves, Clear
(non-colored) | Powder Free Vinyl
Patient
Examination
Gloves, Clear
(non-colored) | Same | | |
| Product Code | LYZ | LYZ | Same | | |
| Size | Small/ Medium/
Large/X large | Small/ Medium/
Large/X large | Same | | |
| Intend for use | Powder Free Vinyl
Patient Examination
Gloves, 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. | Powder Free
Vinyl
Patient
Examination
Gloves, 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. | Same | | |
| Device Description and
Specifications | Meets ASTM
D5250-06 | Meets ASTM
D5250-06
(Reapproved 2011) | Same | | |
| Dimensions
Length
(mm )
ILS-2
AQL4.0 | ≥230mm | 231-241mm | 232-243mm | Same | |
| Dimensions
Width
(mm)
IL S-2
AQL4.0 | Small | 80-90 | 81-89 | 82-88 | Same |
| | Medium | 90-100 | 93-99 | 93-98 | |
| | Large | 100-110 | 102-110 | 102-109 | |
| | X large | 110-120 | 111-1119 | 113-118 | |
| Dimensions
Thickness
(mm )
IL S-2
AQL4.0 | Finger | $\ge$ 0.05 | 0.05-0.10 | 0.08-0.11 | Same |
| | Palm | $\ge$ 0.08 | 0.09-0.13 | 0.10-0.11 | Same |
| Physical
Properties
IL S-2
AQL4.0 | Before aging/after aging | | | | Same |
| | Elongation $\ge$ 300% | | 340-410% | 350-420% | |
| | Tensile Strength
$\ge$ 14MPa | | 15-25 MPa | 15-20 MPa | |
| Freedom
from
Pinholes
Residual
Powder | Holes at
Inspection Level
LAOL2.5
below 2mg of
residual powder | | Holes at
Inspection
Level I | Holes at
Inspection Level I
AOL2.5 | Same |
| | | 0.3mg | | 0.1mg | Same |
| Materials used to fabricate
the devices | | | PVC | PVC | Same |
| Dusting or Donning
Powder: name | | | Surface Coating
Agent | Surface Coating
Agent | Same |
| 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 | Same |
| Single Patient Use | | | Single Patient Use | Single Patient Use | Same |
| Biocompatibility
Irritation and Sensitization
(ISO 10993-10) | | | Under the conditions
of this study, not an
irritant and Under
the conditions of
this study, not a
sensitizer. | Under the
conditions
of this study, not
an irritant and
Under the
conditions of this
study, not a
sensitizer. | Same |
| Cytotoxicity
(ISO 10993-5) | | | / | Under the
conditions of this
study, the test
article was
non-cytotoxicity
to L-929 cells. | |
| Labeling. | | | -Powder Free
-Patient
Examination
Glove
-Single Use Only
- Manufactured For:
- Lot | -Powder Free
-Patient
Examination
Glove
-Single Use Only - Manufactured For:
- Lot | Same |
5
6
7.0 Summary of Non-Clinical Performance Data:
Non-clinical tests were conducted to verify that the proposed device will meet acceptance criteria for each test. The test results demonstrated that the proposed device met the acceptance criteria found in the following standards below:
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| Length | |
| Width | |
| Thickness | |
| Physical | |
| Properties | |
| Powder Residual | ASTM standard D 5250-06 (Reapproved |
| 2011).and D6124-06(Reaffirmation 2011) Meets |