(111 days)
Not Found
No
The device description and performance studies focus on material properties and ASTM standards, with no mention of AI or ML.
No.
The device is a non-sterile disposable glove intended to prevent contamination between patient and examiner and does not treat or alleviate any condition.
No
Explanation: The device is a non-sterile disposable glove intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly describes a physical product (gloves made of PVC) and its material properties and performance standards, indicating it is 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 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 (material, strength, flexibility, barrier function) and its conformity to standards for examination gloves. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information based on specimen analysis
- Reagents, calibrators, or controls
This device is a medical device, specifically a Class I medical device (examination glove), but it falls under the category of devices used for protection and barrier function, not for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes
LYZ
Device Description
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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
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)
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) meet requirements per ASTM D5250-06(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10 Third Edition 2010-08-01.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three faces overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Tangshan Hongyun Plastic Products Co., Ltd. C/O Mr. Chu Xiaoan Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Room 1606 Bldg. 1 Beijing, 100083 CHINA
Re: K142343
Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Vinyl Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: October 24, 2014 Received: October 30, 2014
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.
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. 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
2
Indications for Use
510(k) Number (if known) K 142343
Device Name
Powder-Free Vinyl Patjent Examination Gloves, Clear (Non-colored)
Indications for Use (Describe)
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.
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 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 : | Tangshan Hongyun Plastic Products Co.,ltd |
|---|---|
| Submitter's address : | South Shenggezhuang Village, Pachigang Town, Luannan |
| County, 063502,Hebei Province,China | |
| Phone number : | (86)315-4169377 |
| Fax number : | (86)315-4169376 |
| Name of contact person: | RJ Wang |
| Date the summary was prepared: | 2014-10-24 |
[(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 Vinyl Patient Examination Gloves, Clear (Non-colored) |
|---|---|
| Proprietary/Trade name: | " Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)" |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| 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 Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd.. K120968 .
4
[(a)(4)] A description of the device
Device Description : Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) 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 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.
[(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 | Tangshan Zhonghong Plastic Co.,Ltd. | Tangshan Hongyun Plastic Products Co.,ltd | -- |
| 510(K) Number | K120968 | K142343 | |
| 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 | Substantially
equivalent |
| 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. | 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 |
| | 232-249mm | 231-250 mm | |
| Dimensions
-- Width | Meets ASTM D5250-06
(Reapproved 2011) | Meets ASTM D5250-06
(Reapproved 2011) | Substantially
equivalent |
| | Small 80-90 mm
Medium 90-100mm
Large 100-110mm
X large 110-120 mm | Small 84-87 mm
Medium 94-97 mm
Large 103-107mm
X large 111-114 mm | |
| Dimensions
-- Thickness | Meets ASTM D5250-06
(Reapproved 2011) | Meets ASTM D5250-06
(Reapproved 2011) | Substantially
equivalent |
The Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored) non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
5
| Physical Properties | Finger 0.08-0.10mm.
Palm: 0.08-0.10mm.
Meets ASTM D5250-06
(Reapproved 2011) | | | Finger: 0.08-0.10mm.
Palm: 0.08-0.11mm.
Meets ASTM D5250-06
(Reapproved 2011) | | | Substantially
equivalent |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------|-----------------------------|
| | Elongation | Before
aging | After
aging | Elongation | Before
aging | After aging | |
| | Tensile
Strength | 360-500% | 350-400% | Tensile
Strength | 330-420% | 350-410% | |
| Freedom from
Pinholes | Meets
• 21 CFR 800.20
• ASTM D5250-06
(Reapproved 2011)
• ASTM D 5151-06
(Reapproved 2011) | | | Meets ASTM D5151-06
(Reapproved 2011)
Holes
Inspection Level I
AQL2.5 | | | Substantially
equivalent |
| Residual Powder | Meets ASTM D6124-06
(Reaffirmation 2011)
Residual powder mean 1.7mg | | | Meets ASTM D6124-06
(Reaffirmation 2011)
Residual powder mean 0.6mg | | | 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 | | | 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
(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:
Clear(Non-colored)
-Patient Examination Glove
-Non sterile
-Single Use Only
- Manufactured For:
- Lot | | | -Powder Free
-devices color:
Clear(Non-colored)
-Patient Examination Glove
-Non sterile
-Single Use Only - Manufactured For:
- Lot | | | Substantially
equivalent |
[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.
Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored)meet requirements per ASTM 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.
6
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 or better than 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 Vinyl Patient Examination Gloves, Clear (Non-colored) is as safe, as effective, and performs as well as the predicate device, Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd. K120968 .