(129 days)
K 141623
Not Found
No
The 510(k) summary describes a standard patient examination glove and does not mention any AI or ML components or functionalities.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is not designed to treat or cure any medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is protective, not diagnostic.
No
The device is a physical patient examination glove made of nitrile latex compound, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hands or fingers. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is described as a patient examination glove made from nitrile latex. This is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The testing mentioned (biocompatibility, chemotherapy drug permeability) relates to the glove's performance as a barrier and its safety for the user and patient, not to diagnosing a condition.
The testing for chemotherapy drug permeation is a performance characteristic of the glove as a protective barrier, not an indication that it is an IVD.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Shandong Baisheng Medical Products Co., Ltd. glove production are based on ASTM-D-6319-05. All testing passed for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
Gloves were tested and meet the "Powder-free" claim (contain no more than 2 mg powder per glove).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Carmustine (BCNU) (3.3 mg/ml): 13.6 minutes
Cisplastin, (1.0 mg/ml): >240 minutes
Cyclophosphamide (20 mg/ml): >240 minutes
Doxorubicin HCl (2.0 mg/ml): >240 minutes
Etoposide (Toposar) (20 mg/ml): >240 minutes
Fluorouracil (50 mg/ml): >240 minutes
Methotrexate (25 mg/ml): >240 minutes
Mitomycin C (0.5 mg/ml): >240 minutes
Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes
Thiotepa (10 mg/ml): 26.9 minutes
Vincristine Sulfate (1 mg/ml): >240 minutes
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.
K 141623
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.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble water or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2016
Shandong Baisheng Medical Products Co., Ltd. % John Zhao Official Correspondence Basic Medical Industries, Inc. 805 Barrington Ave Ontario, California 91764
Re: K161944
Trade/Device Name: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: October 7, 2016 Received: October 19, 2016
Dear John Zhao:
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161944
Device Name
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| | Chemotherapy Drug and
Concentration | Minimum Breakthrough Detection
Time ( Minutes ) |
|-----|----------------------------------------|----------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 13.6 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Mitomycin C (0.5 mg/ml) | >240 |
| 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 10. | Thiotepa (10 mg/ml) | 26.9 |
| 11. | Vincristine Sulfate (1 mg/ml) | >240 |
Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively.
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)
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3
Image /page/3/Picture/0 description: The image shows a black hand with five fingers inside of a square with rounded corners. The hand is facing forward with the fingers spread apart. The hand appears to be wearing a glove or some type of protective covering. The background of the square is white.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
510 (K) SUMMARY
Shandong Baisheng Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
| Manufacturer: | Shandong Baisheng Medical Products Co., Ltd.
11 Longshan Road, Wo long Industry Park
Linqu, Shandong, China |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | John Zhao,
805 Barrington Ave
Ontario, CA 91764 |
| Telephone Number: | (909) 980-1678 |
| Fax Number: | (909) 980-1758 |
| Date Summary Prepared: | November 8, 2016 |
| Product Trade Name: | Shandong Baisheng Medical Products Co., Ltd.
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue
Color, and Tested for Use with Chemotherapy Drugs |
| Device Classification Name: | Patient Examination gloves (21 CFR 880.6250). |
| Device Class : | Class 1. |
| Product Code : | LZA and LZC. |
4
Image /page/4/Picture/0 description: The image shows a black and white icon of a hand wearing a glove. The hand is facing upwards with the fingers spread apart. The glove covers the entire hand and wrist. The icon is enclosed in a square with rounded corners.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
Predicate Devices:
K 141623 - Eco Medi Glove SDN BHD. EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs
New device
The subject device in this 510(k) Notification is Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
The Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs, 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 Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner .
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Reason for 510(k) Submission:
Device Description:
Intended Use:
5
Image /page/5/Picture/0 description: The image shows a black and white drawing of a hand. The hand is facing upwards with the fingers spread apart. The hand appears to be wearing a glove or some type of protective covering. The image is enclosed in a square border.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
| | Chemotherapy Drug and
Concentration | Minimum Breakthrough Detection
Time ( Minutes ) |
|-----|----------------------------------------|----------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 13.6 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 6. | Fluorouracil (50 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Mitomycin C (0.5 mg/ml) | >240 |
| 9. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 10. | Thiotepa (10 mg/ml) | 26.9 |
| 11. | Vincristine Sulfate (1 mg/ml) | >240 |
Table 1: Chemotherapy Drug Permeation Time
CAUTION: Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26. 9 minutes, respectively.
Comparison to Predicate Devices:
Shandong Baisheng Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs, are substantially equivalent in safety and effectiveness to the ECO MEDI GLOVE SDN. BHD. Powder-Free Nitrile Patient Examination Gloves with Tested for use with Chemotherapy Drugs.
Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Shandong Baisheng Medical Products Co., Ltd. glove production are based on ASTM-D-6319-05. All testing passed for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements, Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
6
Image /page/6/Picture/0 description: The image shows a black and white drawing of a hand. The hand is facing upwards and slightly to the left. The hand is wearing a glove that ends at the wrist. The glove appears to be made of a thick material.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
Gloves were tested and meet the "Powder-free" claim (contain no more than 2 mg powder per glove).
Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
Substantial Equivalence:
The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features.
7
Image /page/7/Picture/0 description: The image shows a black and white drawing of a hand inside of a square. The hand is facing upwards and has five fingers. The hand appears to be wearing a glove or some type of protective covering.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
Table 2: Comparison between the device and predicate device
| Characteristics | Acceptance Criteria | Shandong Baisheng
Medical Products
Co., Ltd.
Synthetic Nitrile
Patient Examination
Gloves, Powder
Free, Blue Color,
and Tested for Use
with Chemotherapy
Drugs | EMG Blue Nitrile
Examination Gloves
Powder Free with
Tested for Use with
Chemotherapy Drugs |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K-Number | | K161944 | K141623 |
| Product Code | LZA, LZC | LZA, LZC | LZA, LZC |
| Intended use | 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. | A patient
examination glove is
a disposable device
intended for medical
purposes that is worn
upon the examiner's
hands or finger to
prevent
contamination
between patient and
examiner. | 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. The
device is for over-
the-counter use. |
| Material used | Nitrile | Nitrile | Nitrile |
| Color | Blue | Blue | Blue |
| Single use | Single Use | Yes | Yes |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile |
| Dimensions | Overall Length
(mm) Min
270mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm
(mm)
Min; 0.10mm
Thickness at Finger | Meets ASTM
D6319-10 | Meets ASTM
D6319-10 |
| | Tip (mm) Min 0.10
mm | | |
| Physical
properties | Before Ageing
Tensile Strength
(MPa) = 14min
Ultimate Elongation
(%) = 500min
After Aging at 70°C
for
168 hrs @ 100°C for
22 hrs
Tensile Strength
(MPa) = 14min
Ultimate Elongation
(%) = 400min | Meets ASTM
D6319-10 | Meets ASTM
D6319-10 |
| Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | Meets ASTM
D5151-06 | Meets ASTM
D5151-06 |
| Residual
Powder | 240 min. | Breakthrough time :
240 min. |
| | | 3)Cyclophosphamide
(20mg/ml or
20,000ppm), | 3) Cytarabine
(100mg/ml or
100,000ppm), |
| | | Breakthrough time :
240 min. | Breakthrough time :
240 min. |
| | | 4) Cytarabine
(100mg/ml or
100,000ppm), | 4)Doxorubicin
Hydrochloride
(2.0mg/ml or
2000ppm), |
| | Standards Practice
for Assessment of
resistance of
Medical Glove to
Permeation by
Chemotherapy drugs
ASTM D6978-
05(2013) | Breakthrough time :
240 min. | Breakthrough time:
240 min. |
| Resistance
against
Chemotherapy
Drugs | | 5) Doxorubicin
Hydrochloride
(2.0mg/ml or
2000ppm), | 5) Etoposide
(20mg/ml or
20,000ppm), |
| | | Breakthrough time :
240 min. | Breakthrough time :
240 min. |
| | | 6) Etoposide
(20mg/ml or
20,000ppm), | 6) Flourouracil
(50mg/ml or
50,000), |
| | | Breakthrough time :
240 min. | Breakthrough
time : >240 min. |
| | | 7) Flourouracil
(50mg/ml or
50,000ppm), | 7) Methotrexate
(25mg/ml or
25,000ppm), |
| | | Breakthrough
time : >240 min. | Breakthrough
time : >
240 min. |
| | 8) Methorexate
(25mg/ml or
25,000ppm),
Breakthrough
time : >
240 min.
- Paclitaxel
(6mg/ml or
6,000ppm),
Breakthrough time :
240 min.
- Thiotepa
(10mg/ml or
10,000ppm),
Breakthrough time :
26.9 min
11)Vincristine
Sulfate (1mg/ml
or1000ppm)
Breakthrough time :
240 min. | 8) Paclitaxel
(6mg/ml or
6,000ppm),
Breakthrough time :
240 min.
- Thiotepa
(10mg/ml or
10,000ppm),
Breakthrough time:
63.9 min | |
1
8
Image /page/8/Picture/0 description: The image shows a black and white drawing of a hand wearing a glove. The glove covers the entire hand and extends up the wrist. The drawing is simple and the hand is facing forward.
11 Longshan Road, Wolong Industry Park
Linqu, Shandong, China
Tel: 0086-536-7510508
9
Image /page/9/Picture/0 description: The image shows a black hand wearing a glove. The hand is facing forward with the fingers pointing upwards. The glove appears to be made of a thick material, and it covers the entire hand and wrist. The image is set against a white background and is enclosed in a square with rounded corners.
Shandong Baisheng Medical Products Co., Ltd.
10
Image /page/10/Picture/0 description: The image shows a black and white drawing of a left hand. The hand is facing upwards and slightly tilted to the left. The fingers are spread apart, and the palm is visible. The drawing is simple and stylized, with no background or other details.
11 Longshan Road, Wolong Industry Park Linqu, Shandong, China Tel: 0086-536-7510508
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that Shandong Baisheng Medical Product Co., Ltd. Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K161944) is as safe, as effective, and performs as well as the legally marketed predicate device K141623, EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs.