(540 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 described as a non-sterile disposable glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device is a glove intended to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of PVC, intended to be worn on the hand or finger. It describes physical properties and testing related to the material and structure of the glove, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as 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 for protection during physical examination, not a device used to examine specimens in vitro (outside of the body) to diagnose a condition.
- Device Description: The description focuses on the physical properties of the glove (PVC film, barrier to body fluids and bloodborne pathogens, tensile properties) and its conformity to ASTM standards for examination gloves. 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:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Use in a laboratory setting for diagnostic purposes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
This device falls under the category of a medical device used for barrier protection during patient examination.
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 (comma separated list FDA assigned to the subject device)
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 / Not Found
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 data submitted includes:
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: 2002/Amd. 1:2006(E).
The test article was not an irritant and not a sensitizer. SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 :2002/Amd.1:2006.
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Elongation ≥300%
Tensile Strength≥ 14MPa
Freedom from Pinholes AQL 2.5
Residual Powder Results generated values below 2mg of residual powder
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 a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Dahoon Plastic Company Limited C/O Mr. Chu Xiaoan Official Correspondent Room 1606 Bldg.1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road Haidian District Beijing, 100083 CHINA
Re: K130742
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 8, 2014 Received: August 11, 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.
1
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); 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/MedicalDevicesforYou/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 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,
Image /page/1/Picture/6 description: The image shows the FDA logo. The logo is a stylized version of the letters FDA. The letters are white and are outlined in a darker shade of gray. The logo is simple and modern.
Digitally signed by Richard C. Chapman -S Date: 2014.09.10 16:59:06 -04'00'
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 130742
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 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
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 : | Dahoon Plastic Co., Ltd. |
|---|---|
| Submitter's address : | No.55, Xinshi Zhong Rd. Shijiazhuang, 050000, China |
| Phone number : | (86) 311-67699828 |
| Fax number : | (86) 311-67699906 |
| Name of contact person: | Mr. Zhao Xin Min |
| Date the summary was prepared: | 2014-08-08 |
[(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: | "Dahoon Powder Free Vinyl Patient Examination Gloves." |
| 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), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .
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 | Shijiazhuang Fuguan Plastic | ||
| Products Co., Ltd. | Dahoon Plastic Co., Ltd. | -- | |
| 510(K) Number | K032908 | K130742 | |
| 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) | 230mm min for all sizes | Substantially | |
| equivalent | |||
| Dimensions | |||
| -- Width | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | |||
| ≥230mm min. | |||
| Small 80-90 mmr | |||
| Medium 90-100mm | |||
| Large 100-110mm | |||
| X large 110-120 mm | Small 80-85 mm | ||
| Medium 95-97 mm | |||
| Large 102-108mm | |||
| X large 114-118 mm | Substantially | ||
| equivalent | |||
| Dimensions | |||
| -- Thickness | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | Substantially | ||
| equivalent | |||
| Finger 0.05mm min. | |||
| Palm 0.08mm min. | Finger 0.05mm min. | ||
| Palm 0.08mm min. | |||
| Physical Properties | Meets ASTM D5250-06 | ||
| (Reapproved 2011) | Before aging/after aging | Substantially | |
| equivalent | |||
| Before aging/after aging | |||
| Elongation ≥300% | |||
| Tensile Strength≥14MPa | 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 ASTM | ||
| D5151-06 (Reapproved 2011) | |||
| Holes | |||
| Inspection Level I | |||
| AQL2.5 | Substantially | ||
| equivalent | |||
| Residual Powder | Meets ASTM | ||
| D 6124-06 | |||
| (Reapproved 2011) | D 6124-06 | ||
| (Reapproved 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 | 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 | Meets | ||
| ASTM D5151-06 | |||
| (Reapproved 2011) | |||
| ASTM D5250-06 | |||
| (Reapproved 2011) | |||
| ASTM D6124-06 | Substantially | ||
| equivalent | |||
| Single Patient Use | Single Patient Use | Single Patient Use | Substantially |
| equivalent | |||
| Biocompatibility | SKIN IRRITATION DERMAL | ||
| and SENSITIZATION | |||
| STUDIES Meets ISO | |||
| 10993-10 :2002/Amd.1:2006 | The test article was not an | ||
| irritant and not a sensitizer. | |||
| SKIN IRRITATION DERMAL | |||
| and SENSITIZATION | |||
| STUDIES Meets ISO | |||
| 10993-10 :2002/Amd.1:2006 | 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 |
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
[(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: 2002/Amd. 1:2006(E).
[(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.
6
[(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), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .