(129 days)
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.
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 provided document describes the acceptance criteria and performance of "Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs" manufactured by Shandong Baisheng Medical Products Co., Ltd. (K161944).
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared against a predicate device (EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs, K141623) and general acceptance criteria based on relevant ASTM standards.
| Characteristics | Acceptance Criteria | Reported Device Performance (Shandong Baisheng Medical Products Co., Ltd.) |
|---|---|---|
| K-Number | N/A (Internal ID) | K161944 |
| Product Code | 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. |
| Material used | Nitrile | Nitrile |
| Color | Blue | Blue |
| Single use | Single Use | Yes |
| 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 Tip (mm) Min 0.10mm | Meets ASTM D6319-10 |
| 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 |
| Freedom from pinholes | AQL 2.5 Inspection Level G-1 | Meets ASTM D5151-06 |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D5151-06 (also explicitly stated as "contain no more than 2 mg powder per glove") |
| Biological Evaluation - Primary Skin Irritation Test | N/A (Implicitly, non-irritant) | Under the conditions of this study, the test article was a non-irritant. |
| Biological Evaluation - Dermal Sensitization Assay | N/A (Implicitly, non-sensitizer) | Under the conditions of this study, the test article was a non-sensitizer. |
| Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASTM D6978-05(2013) | Carmustine (3.3mg/ml): Breakthrough: 13.6 min Cisplastin (1.0mg/ml): Breakthrough time: >240 min Cyclophosphamide (20mg/ml): Breakthrough time: >240 min Doxorubicin Hydrochloride (2.0mg/ml): Breakthrough time: >240 min Etoposide (20mg/ml): Breakthrough time: >240 min Fluorouracil (50mg/ml): Breakthrough time: >240 min Methotrexate (25mg/ml): Breakthrough time: >240 min Mitomycin C (0.5 mg/ml): Breakthrough time: >240 min Paclitaxel (6mg/ml): Breakthrough time: >240 min Thiotepa (10mg/ml): Breakthrough time: 26.9 min Vincristine Sulfate (1mg/ml): Breakthrough time: >240 min |
Notes on Chemotherapy Drug Resistance: The document itself highlights: "Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 13.6 and 26.9 minutes, respectively."
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific "test set" sample size for each performance test in typical terms used for AI/clinical studies. Instead, it refers to standard inspection levels and AQLs for physical properties and details for the chemotherapy drug permeation testing.
- Physical and Dimensions Testing: "Inspection Level S-2, AQL 2.5." This refers to sampling plans defined in quality control standards, not a fixed sample size. The specific sample size would depend on the lot size being tested.
- FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, Inspection Level I". Similar to above, this is a sampling plan.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization) Testing: No specific sample size is mentioned, but implies in vivo testing (likely on animals or human volunteers for sensitization, but often animal models for irritation).
- Chemotherapy Drug Permeation Testing: No specific number of gloves or replicates is stated in the provided text, but it's done "in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs". This standard would define the methodology and number of test specimens.
Data Provenance: The tests appear to have been performed specifically for the purpose of this 510(k) submission, thus they are prospective for the device's regulatory clearance. The manufacturer is "Shandong Baisheng Medical Products Co., Ltd." located in Linqu, Shandong, China, suggesting the testing was performed, or overseen, in relation to their manufacturing activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a medical glove, not an AI or diagnostic device that requires expert ground truth for interpretation. The "ground truth" for the performance criteria are objective measurements from laboratory tests following established ASTM standards.
4. Adjudication method for the test set
This is not applicable for the same reasons as #3. No expert adjudication is involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document evaluates a medical glove, not an AI assistant or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document evaluates a medical glove.
7. The type of ground truth used
The ground truth for the performance criteria is established through objective laboratory measurements and tests conforming to recognized industry standards (primarily ASTM D6319-10, ASTM D5151-06, and ASTM D6978-05(2013)).
- Physical properties: Measured parameters like tensile strength, elongation, dimensions against the standard's requirements.
- Freedom from pinholes: Based on water leak tests and statistical sampling (AQL).
- Residual Powder: Gravimetric measurement (mg/glove).
- Biocompatibility: Results of specific irritation and sensitization assays/protocols.
- Chemotherapy Drug Permeation: Measured breakthrough time of specific chemotherapy agents through the glove material using analytical methods defined in ASTM D6978.
8. The sample size for the training set
This is not applicable. This document describes the testing of a medical glove, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
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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
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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
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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 andConcentration | Minimum Breakthrough DetectionTime ( 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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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 ParkLinqu, Shandong, China |
|---|---|
| Regulatory Affairs Contact: | John Zhao,805 Barrington AveOntario, 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, BlueColor, 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. |
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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:
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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 andConcentration | Minimum Breakthrough DetectionTime ( 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.
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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.
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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 BaishengMedical ProductsCo., Ltd.Synthetic NitrilePatient ExaminationGloves, PowderFree, Blue Color,and Tested for Usewith ChemotherapyDrugs | EMG Blue NitrileExamination GlovesPowder Free withTested for Use withChemotherapy Drugs |
|---|---|---|---|
| K-Number | K161944 | K141623 | |
| Product Code | LZA, LZC | LZA, LZC | LZA, LZC |
| Intended use | A powder freepatient examinationglove is a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | A patientexamination glove isa disposable deviceintended for medicalpurposes that is wornupon the examiner'shands or finger topreventcontaminationbetween patient andexaminer. | A powder freepatient examinationglove is a disposabledevice intended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. Thedevice 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) Min270mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm(mm)Min; 0.10mmThickness at Finger | Meets ASTMD6319-10 | Meets ASTMD6319-10 |
| Tip (mm) Min 0.10mm | |||
| Physicalproperties | Before AgeingTensile Strength(MPa) = 14minUltimate Elongation(%) = 500minAfter Aging at 70°Cfor168 hrs @ 100°C for22 hrsTensile Strength(MPa) = 14minUltimate Elongation(%) = 400min | Meets ASTMD6319-10 | Meets ASTMD6319-10 |
| Freedom frompinholes | AQL 2.5Inspection Level G-1 | Meets ASTMD5151-06 | Meets ASTMD5151-06 |
| ResidualPowder | < 2.0 mg/pc | Meets ASTMD5151-06 | Meets ASTMD5151-06 |
| BiologicalEvaluation onMedicalDevice --Primary SkinIrritationTest | Under the conditionsof this study, the testarticle was a non-irritant. | Under the conditionsof this study, the testarticle was a non-irritant. | |
| BiologicalEvaluation onMedicalDevice -DermalSensitizationAssay | Under the conditionsof this study, the testarticle was a non-sensitizer. | Under the conditionsof this study, the testarticle was a non-sensitizer. | |
| 1) Carmustine(3.3mg/mlor 3000ppm),Breakthrough : 13.6min. | 1) Carmustine(3.3mg/mlor 3000ppm),Breakthrough : 1.3min. | ||
| 2)Cisplastin(1.0mg/ml or10,000ppm) | 2)Cyclophosphamide(20mg/ml or20,000ppm), | ||
| Breakthrough time :>240 min. | Breakthrough time :>240 min. | ||
| 3)Cyclophosphamide(20mg/ml or20,000ppm), | 3) Cytarabine(100mg/ml or100,000ppm), | ||
| Breakthrough time :>240 min. | Breakthrough time :>240 min. | ||
| 4) Cytarabine(100mg/ml or100,000ppm), | 4)DoxorubicinHydrochloride(2.0mg/ml or2000ppm), | ||
| Standards Practicefor Assessment ofresistance ofMedical Glove toPermeation byChemotherapy drugsASTM D6978-05(2013) | Breakthrough time :>240 min. | Breakthrough time:>240 min. | |
| ResistanceagainstChemotherapyDrugs | 5) DoxorubicinHydrochloride(2.0mg/ml or2000ppm), | 5) Etoposide(20mg/ml or20,000ppm), | |
| Breakthrough time :>240 min. | Breakthrough time :>240 min. | ||
| 6) Etoposide(20mg/ml or20,000ppm), | 6) Flourouracil(50mg/ml or50,000), | ||
| Breakthrough time :>240 min. | Breakthroughtime : >240 min. | ||
| 7) Flourouracil(50mg/ml or50,000ppm), | 7) Methotrexate(25mg/ml or25,000ppm), | ||
| Breakthroughtime : >240 min. | Breakthroughtime : >240 min. | ||
| 8) Methorexate(25mg/ml or25,000ppm),Breakthroughtime : >240 min.9) Paclitaxel(6mg/ml or6,000ppm),Breakthrough time :>240 min.10) Thiotepa(10mg/ml or10,000ppm),Breakthrough time :26.9 min11)VincristineSulfate (1mg/mlor1000ppm)Breakthrough time :>240 min. | 8) Paclitaxel(6mg/ml or6,000ppm),Breakthrough time :>240 min.9) Thiotepa(10mg/ml or10,000ppm),Breakthrough time:63.9 min |
1
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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
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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.
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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.
§ 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.