(71 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device is a patient examination glove, intended to prevent contamination, not to treat or cure a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination, not to diagnose medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "Powder free vinyl patient examination glove" and references ASTM standards for physical properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Powder free vinyl patient examination glove" intended to be "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used in vivo (on the body) for protection, not for analyzing specimens in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring analytes.
This device is a Class I medical device (general controls) intended for infection control and barrier protection during patient examinations.
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
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Not Found
Key Metrics
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
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: 15122 89 3" (applicant leave blank)
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 : | Geenli Plastic Co., Ltd. |
|---|---|
| Submitter's address : | #88, Xinshizhong Rd. Shijiazhang, 050000 China |
| Phone number : | (86) 0311-67699886 |
| Fax number : | (86) 0311-67699916 |
| Name of contact person: | Mr. Luo Fei |
| Date the summary was prepared: | Oct. 29, 12 |
[(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 |
| 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 : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .
[(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).
1
[(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.
The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Features &
Description | Predicate Device | Medical Glove
Guidance
Manual(1661) | Subject Device | Result of
Comparison | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|
| Company | Shijiazhuang
Fuguan Plastic
Products Co., Ltd..
K032908 . | | Geenli Plastic Co.,
Ltd. | -- | |
| Product name | Powder Free Vinyl
Patient
Examination
Gloves, Clear
(non-colored) | | Powder Free Vinyl
Patient
Examination
Gloves, Clear (non-
colored) | -- | |
| 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
Examination
Gloves:
A powder-free
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. | 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 | If vinyl:
Do the vinyl
examination
gloves meet all
the current
specifications
listed under
ASTM
Specification
D5250 or an
equivalent
consensus
standard? | Meets ASTM
D5250 | Substantially
equivalent | |
| Compare all
materials used to
fabricate the | PVC | If the glove is
made of a
polymer or other | PVC | Substantially
equivalent | |
| devices | | type of material.
identify the
material. | | | |
| Dusting or
Donning Powder: | PU | If a donning
lubricant is used,
state the
composition and
include
biocompatibility
data for the
lubricant in an
identified
attachment; also
state the name,
manufacturer,
and address
below | PU | Substantially
equivalent | |
| Dusting or
Donning Powder:
name | PU | Lubricant
Generic Name/
Lubricant
Brand Name | Surface Coating
Agent | Substantially
equivalent | |
| Compare product
specifications | Meets ASTM
D5250 | We recommend
you certify that
your finished
"powder-free"
gloves meet the
following:
ASTM D 5250
standard or an
equivalent
standard for
vinyl | Meets ASTM
D5250 | Substantially
equivalent | |
| Compare
performance data
supporting
substantial
equivalence | Meets
ASTM D5151
ASTM D5250
ASTM D6124 | At this time
FDA recognizes
the following
standards:
Patient
Examination
Gloves(PVC)
ASTM
D5151(Detection
of Holes in
Medical Gloves)
ASTM
D6124(Residual
Powder on
Medical Gloves)
ASTM
D5250(Poly(vin
yl chloride)
Gloves) | Meets
ASTM D5151
ASTM D5250
ASTM D6124 | Substantially
equivalent | |
| Single Patient Use | Single Patient Use | Single Patient
Use | Single Patient Use | Substantially
equivalent | |
| Biocompatibility | SKIN
IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets
ISO 10993-10 | SKIN
IRRITATION
DERMAL and
SENSITIZATIO
N STUDIES
ISO 10993-10
Chapter 4 | SKIN
IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets
ISO 10993-10 | Substantially
equivalent | |
| Labeling for the
legally marketed
device to which | -Powder-Free
-Patient
Examination Glove | | -Powder-Free
-Patient
Examination Glove | Substantially
equivalent | |
2
:
:
1
3
| equivalence is | - Manufactured | - Manufactured | |
|---|---|---|---|
| claimed. | For: | For: | |
| - Lot | - Lot |
[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
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 ISO10993-10: 2006 third edition 2010-08-01., it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses. [(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 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 . It is as safe, as effective, and performed as well the legally marketed device identified in (a)(3).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
November 30, 2012
Geenli Plastic Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, China 100083
Re: K122893
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: October 29, 2012 Received: November 1, 2012
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 Eederal Register.
5
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthong Dr. m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
INDICATIONS FOR USE
Applicant: GEENLI PLASTIC CO., LTD
510(k) Number (if known): * K12コ 893
Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications For Use:
Powder free vinyl 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Dialtally sioned by Maria Cruz-fishe Maria Cruz-fishe owlelon Bign-Off)
Ivision of Anesthestology, General Hospit:
Intellion Control, Dental Devices Sivision Sign-Off (Division of Anesthestology of
510(k) Number: J